{
"NDC": [
{
"NDCCode": "70756-608-60",
"PackageDescription": "60 POUCH in 1 CARTON (70756-608-60) / 4 VIAL in 1 POUCH (70756-608-44) / 2 mL in 1 VIAL",
"NDC11Code": "70756-0608-60",
"ProductNDC": "70756-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Formoterol Fumarate",
"NonProprietaryName": "Formoterol Fumarate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215883",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FORMOTEROL FUMARATE",
"StrengthNumber": "20",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230322",
"SamplePackage": "N",
"IndicationAndUsage": "Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation aqueous solution administration by nebulization packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white or almost white or slightly yellow powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus®nebulizer (with a facemask or mouthpiece) connected to a PRONEB®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
},
{
"NDCCode": "70756-608-70",
"PackageDescription": "30 POUCH in 1 CARTON (70756-608-70) / 1 VIAL in 1 POUCH (70756-608-12) / 2 mL in 1 VIAL",
"NDC11Code": "70756-0608-70",
"ProductNDC": "70756-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Formoterol Fumarate",
"NonProprietaryName": "Formoterol Fumarate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215883",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FORMOTEROL FUMARATE",
"StrengthNumber": "20",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230322",
"SamplePackage": "N",
"IndicationAndUsage": "Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation aqueous solution administration by nebulization packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white or almost white or slightly yellow powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus®nebulizer (with a facemask or mouthpiece) connected to a PRONEB®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
},
{
"NDCCode": "70756-006-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (70756-006-60) ",
"NDC11Code": "70756-0006-60",
"ProductNDC": "70756-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220874",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).",
"Description": "Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban, USP is sparingly soluble in dimethyl formamide and practically insoluble in water. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hydroxy propyl methyl cellulose, magnesium stearate, microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), lactose monohydrate, sodium lauryl sulphate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Opadry Yellow containing hypromellose, titanium dioxide, polyethylene glycol 3350, iron oxide yellow. FDA-approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-047-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70756-047-60) ",
"NDC11Code": "70756-0047-60",
"ProductNDC": "70756-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217679",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260206",
"SamplePackage": "N",
"IndicationAndUsage": "Ticagrelor tablets are P2Y12 platelet inhibitor indicated: 1 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 2 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
"Description": "Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-(propylsulfanyl)-3H-[1,2,3] triazolo[4,5-d]-pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.6. The chemical structure of ticagrelor is. Ticagrelor is off white to pale pink powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. It is freely soluble in dimethylsulphoxide, sparingly soluble in methanol, and insoluble in water. Ticagrelor tablets for oral administration contain 60 mg or 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone, and titanium dioxide. The 60 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, and FD&C red #40 aluminum lake. The 90 mg tablets also contain talc."
},
{
"NDCCode": "70756-048-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70756-048-60) ",
"NDC11Code": "70756-0048-60",
"ProductNDC": "70756-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217679",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260206",
"SamplePackage": "N",
"IndicationAndUsage": "Ticagrelor tablets are P2Y12 platelet inhibitor indicated: 1 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 2 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
"Description": "Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-(propylsulfanyl)-3H-[1,2,3] triazolo[4,5-d]-pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.6. The chemical structure of ticagrelor is. Ticagrelor is off white to pale pink powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. It is freely soluble in dimethylsulphoxide, sparingly soluble in methanol, and insoluble in water. Ticagrelor tablets for oral administration contain 60 mg or 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone, and titanium dioxide. The 60 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, and FD&C red #40 aluminum lake. The 90 mg tablets also contain talc."
},
{
"NDCCode": "70756-612-60",
"PackageDescription": "60 POUCH in 1 CARTON (70756-612-60) / 4 VIAL in 1 POUCH (70756-612-44) / 2 mL in 1 VIAL",
"NDC11Code": "70756-0612-60",
"ProductNDC": "70756-612",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arformoterol Tartrate",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20221115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216128",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Arformoterol tartrate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(lR)-1-hydroxy-2-[[(lR)-2-(4-methoxyphenyl)-1- methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1: 1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white powder that is freely soluble in dimethyl sulfoxide, sparingly soluble in water, slightly soluble in methanol, practically insoluble in acetonitrile. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information)."
},
{
"NDCCode": "70756-703-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70756-703-60) ",
"NDC11Code": "70756-0703-60",
"ProductNDC": "70756-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212284",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran and acetonitrile slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) Type A, microcrystalline cellulose, polysorbate 80, sodium hydroxide and sodium lauryl sulphate. Additional inactive ingredients for the 500 mg tablet include macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide. Additional inactive ingredients for the 1000 mg tablet include iron oxide yellow, macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "70756-704-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70756-704-60) ",
"NDC11Code": "70756-0704-60",
"ProductNDC": "70756-704",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212284",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran and acetonitrile slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) Type A, microcrystalline cellulose, polysorbate 80, sodium hydroxide and sodium lauryl sulphate. Additional inactive ingredients for the 500 mg tablet include macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide. Additional inactive ingredients for the 1000 mg tablet include iron oxide yellow, macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "70756-811-65",
"PackageDescription": "1 TUBE in 1 CARTON (70756-811-65) > 60 g in 1 TUBE",
"NDC11Code": "70756-0811-65",
"ProductNDC": "70756-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170714",
"EndMarketingDate": "20210630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207741",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Polyene Antifungal [EPC],Polyenes [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170714",
"EndMarketingDatePackage": "20210630",
"SamplePackage": "N"
},
{
"NDCCode": "70756-815-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70756-815-60) ",
"NDC11Code": "70756-0815-60",
"ProductNDC": "70756-815",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211724",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1) perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1) treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1) Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated. (1.2) treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. (1.2) Gastric, Esophageal, or Gastroesophageal Junction Cancer treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (1.3) treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. (1.3) Pancreatic Cancer adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. (1.4).",
"Description": "Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N- [(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine Tablets, USP are supplied as biconvex, oblong film-coated tablets for oral use. Each light peach- colored tablet debossed with ‘C150’ on one side and plain on other side contains 150 mg of capecitabine USP and each peach colored tablet debossed with ‘C500’ on one side and plain on other side contains 500 mg of capecitabine USP. The inactive ingredients in capecitabine include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate. The peach or light peach film coating contains hydroxypropyl methylcellulose, polyethylene glycol, red iron oxides, synthetic yellow, talc and titanium dioxide."
},
{
"NDCCode": "25000-608-06",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-608-06) ",
"NDC11Code": "25000-0608-06",
"ProductNDC": "25000-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090723",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220527",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive Ingredients include sugar spheres (contains sugar and corn starch), hypromellose, glycine, sucrose, talc, hypromellose phthalate, triethyl citrate, gelatin, titanium dioxide, FD&C Blue 2, sodium lauryl sulfate, shellac and iron oxide yellow. The 20 mg capsules also contain black iron oxide and potassium hydroxide. The 60 mg capsules also contain potassium hydroxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "45963-608-60",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (45963-608-60) > 100 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "45963-0608-60",
"ProductNDC": "45963-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epirubicin Hydrochloride",
"NonProprietaryName": "Epirubicin Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065445",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "EPIRUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20111128",
"EndMarketingDatePackage": "20201031",
"SamplePackage": "N"
},
{
"NDCCode": "49999-608-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49999-608-60)",
"NDC11Code": "49999-0608-60",
"ProductNDC": "49999-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040409",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2016-03-11"
},
{
"NDCCode": "53489-608-06",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (53489-608-06)",
"NDC11Code": "53489-0608-06",
"ProductNDC": "53489-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077520",
"LabelerName": "Mutual Pharmaceutical Company, Inc.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principle metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β, 8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg, and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: butylated hydroxyanisole (BHA), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Additionally, lovastatin 10 mg contains pigment blend light orange, lovastatin 20 mg contains FD&C Blue #2 Aluminum Lake, and lovastatin 40 mg contains Lake blend green."
},
{
"NDCCode": "55111-608-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (55111-608-60)",
"NDC11Code": "55111-0608-60",
"ProductNDC": "55111-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090723",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "58411-608-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-608-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0608-60",
"ProductNDC": "58411-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum Spf 20 Sunscreen",
"ProprietaryNameSuffix": "5c1 Nutmeg",
"NonProprietaryName": "Octinoxate And Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211130",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "2.827; 1.542",
"StrengthUnit": "g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211130",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "58602-608-01",
"PackageDescription": "1 CAN in 1 CARTON (58602-608-01) / 60 g in 1 CAN",
"NDC11Code": "58602-0608-01",
"ProductNDC": "58602-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil 5% (for Men)",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218616",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)."
},
{
"NDCCode": "58602-608-02",
"PackageDescription": "2 CAN in 1 CARTON (58602-608-02) / 60 g in 1 CAN",
"NDC11Code": "58602-0608-02",
"ProductNDC": "58602-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil 5% (for Men)",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218616",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)."
},
{
"NDCCode": "58602-608-03",
"PackageDescription": "3 CAN in 1 CARTON (58602-608-03) / 60 g in 1 CAN",
"NDC11Code": "58602-0608-03",
"ProductNDC": "58602-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil 5% (for Men)",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218616",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)."
},
{
"NDCCode": "58602-608-04",
"PackageDescription": "4 CAN in 1 CARTON (58602-608-04) / 60 g in 1 CAN",
"NDC11Code": "58602-0608-04",
"ProductNDC": "58602-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil 5% (for Men)",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218616",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)."
},
{
"NDCCode": "58602-608-05",
"PackageDescription": "6 CAN in 1 CARTON (58602-608-05) / 60 g in 1 CAN",
"NDC11Code": "58602-0608-05",
"ProductNDC": "58602-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil 5% (for Men)",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218616",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)."
},
{
"NDCCode": "58980-608-60",
"PackageDescription": "1 BOTTLE in 1 BOX (58980-608-60) > 177.42 mL in 1 BOTTLE",
"NDC11Code": "58980-0608-60",
"ProductNDC": "58980-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Urea",
"NonProprietaryName": "Urea",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100520",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Stratus Pharmaceuticals, Inc",
"SubstanceName": "UREA",
"StrengthNumber": "1",
"StrengthUnit": "mL/10mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "61919-608-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-608-60) ",
"NDC11Code": "61919-0608-60",
"ProductNDC": "61919-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"ProprietaryNameSuffix": "E/r",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075492",
"LabelerName": "DIRECTRX",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190404",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets and other treatment options before deciding to use Diclofenac Sodium Extended-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac Sodium Extended-release Tablets are indicated. For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac Sodium Extended-release Tablets are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. [Chemical Structure]. Each extended-release tablet for oral administration contains 100 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D & C Red # 27 (phloxine aluminum lake), hydroxyethyl cellulose, hypromellose, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "65841-608-14",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (65841-608-14) ",
"NDC11Code": "65841-0608-14",
"ProductNDC": "65841-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079017",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N"
},
{
"NDCCode": "66215-608-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (66215-608-06) / 60 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "66215-0608-06",
"ProductNDC": "66215-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uptravi",
"NonProprietaryName": "Selexipag",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207947",
"LabelerName": "Actelion Pharmaceuticals US, Inc.",
"SubstanceName": "SELEXIPAG",
"StrengthNumber": "800",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151221",
"SamplePackage": "N",
"IndicationAndUsage": "UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): 1 In adults to delay disease progression and reduce the risk of hospitalization for PAH. (1.1), 2 In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. (1.1).",
"Description": "UPTRAVI contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide. It has a molecular formula of C26H32N4O4S and a molecular weight of 496.62. Selexipag has the following structural formula. Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. UPTRAVI® (selexipag) tablets: depending on the dose strength, each round film-coated tablet for oral administration contains 100, 150, 200, 400, 600, 800, 1,000, 1,200, 1,400, or 1,600 mcg of selexipag. The tablets include the following inactive ingredients: corn starch, D-mannitol, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, and magnesium stearate. The tablets are film coated with a coating material containing carnauba wax, hypromellose, propylene glycol, titanium dioxide, along with mixtures of iron oxide black, iron oxide red and/or iron oxide yellow. The coating material of the 100 mcg and 150 mcg tablets also contains talc. UPTRAVI® (selexipag) for injection: contains 1,800 mcg of selexipag per vial. UPTRAVI for injection includes the following inactive ingredients: glycine (180 mg), phosphoric acid (3.53 mg), polysorbate 20 (10.8 mg) and sodium hydroxide (for pH adjustment). UPTRAVI for injection is provided in 10 mL Type I clear glass vials closed by a stopper and tear-off aluminum seal."
},
{
"NDCCode": "66267-608-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (66267-608-60) ",
"NDC11Code": "66267-0608-60",
"ProductNDC": "66267-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071141",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161227",
"SamplePackage": "N"
},
{
"NDCCode": "66336-608-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (66336-608-60)",
"NDC11Code": "66336-0608-60",
"ProductNDC": "66336-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Misoprostol",
"NonProprietaryName": "Misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091227",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019268",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "MISOPROSTOL",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.",
"Description": "Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±). Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "70445-608-03",
"PackageDescription": "60 mL in 1 BOTTLE (70445-608-03) ",
"NDC11Code": "70445-0608-03",
"ProductNDC": "70445-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scented Hand Sanitizer",
"NonProprietaryName": "Scented Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240820",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Beacon Promotions, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "63.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240820",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help decrease bacteria on the skin."
},
{
"NDCCode": "71205-608-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-608-60) ",
"NDC11Code": "71205-0608-60",
"ProductNDC": "71205-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207799",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210930",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injuryPediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) contain red iron oxide, yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "71610-608-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-608-60) ",
"NDC11Code": "71610-0608-60",
"ProductNDC": "71610-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2021-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211026",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70756-608-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (70756-608-60) / 4 VIAL in 1 POUCH (70756-608-44) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>70756-0608-60</NDC11Code>
<ProductNDC>70756-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Formoterol Fumarate</ProprietaryName>
<NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215883</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation aqueous solution administration by nebulization packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white or almost white or slightly yellow powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus®nebulizer (with a facemask or mouthpiece) connected to a PRONEB®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
</NDC>
<NDC>
<NDCCode>70756-608-70</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (70756-608-70) / 1 VIAL in 1 POUCH (70756-608-12) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>70756-0608-70</NDC11Code>
<ProductNDC>70756-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Formoterol Fumarate</ProprietaryName>
<NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215883</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation aqueous solution administration by nebulization packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is. Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2C4H4O42H2O. Formoterol fumarate dihydrate, USP is a white or almost white or slightly yellow powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus®nebulizer (with a facemask or mouthpiece) connected to a PRONEB®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
</NDC>
<NDC>
<NDCCode>70756-006-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (70756-006-60) </PackageDescription>
<NDC11Code>70756-0006-60</NDC11Code>
<ProductNDC>70756-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220874</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).</IndicationAndUsage>
<Description>Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban, USP is sparingly soluble in dimethyl formamide and practically insoluble in water. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hydroxy propyl methyl cellulose, magnesium stearate, microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), lactose monohydrate, sodium lauryl sulphate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Opadry Yellow containing hypromellose, titanium dioxide, polyethylene glycol 3350, iron oxide yellow. FDA-approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-047-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70756-047-60) </PackageDescription>
<NDC11Code>70756-0047-60</NDC11Code>
<ProductNDC>70756-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217679</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ticagrelor tablets are P2Y12 platelet inhibitor indicated: 1 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 2 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).</IndicationAndUsage>
<Description>Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-(propylsulfanyl)-3H-[1,2,3] triazolo[4,5-d]-pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.6. The chemical structure of ticagrelor is. Ticagrelor is off white to pale pink powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. It is freely soluble in dimethylsulphoxide, sparingly soluble in methanol, and insoluble in water. Ticagrelor tablets for oral administration contain 60 mg or 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone, and titanium dioxide. The 60 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, and FD&C red #40 aluminum lake. The 90 mg tablets also contain talc.</Description>
</NDC>
<NDC>
<NDCCode>70756-048-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70756-048-60) </PackageDescription>
<NDC11Code>70756-0048-60</NDC11Code>
<ProductNDC>70756-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217679</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ticagrelor tablets are P2Y12 platelet inhibitor indicated: 1 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM). (1.2), 2 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).</IndicationAndUsage>
<Description>Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-(propylsulfanyl)-3H-[1,2,3] triazolo[4,5-d]-pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.6. The chemical structure of ticagrelor is. Ticagrelor is off white to pale pink powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. It is freely soluble in dimethylsulphoxide, sparingly soluble in methanol, and insoluble in water. Ticagrelor tablets for oral administration contain 60 mg or 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone, and titanium dioxide. The 60 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, and FD&C red #40 aluminum lake. The 90 mg tablets also contain talc.</Description>
</NDC>
<NDC>
<NDCCode>70756-612-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (70756-612-60) / 4 VIAL in 1 POUCH (70756-612-44) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>70756-0612-60</NDC11Code>
<ProductNDC>70756-612</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arformoterol Tartrate</ProprietaryName>
<NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20221115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216128</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Arformoterol tartrate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(lR)-1-hydroxy-2-[[(lR)-2-(4-methoxyphenyl)-1- methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1: 1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white powder that is freely soluble in dimethyl sulfoxide, sparingly soluble in water, slightly soluble in methanol, practically insoluble in acetonitrile. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information).</Description>
</NDC>
<NDC>
<NDCCode>70756-703-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70756-703-60) </PackageDescription>
<NDC11Code>70756-0703-60</NDC11Code>
<ProductNDC>70756-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212284</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran and acetonitrile slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) Type A, microcrystalline cellulose, polysorbate 80, sodium hydroxide and sodium lauryl sulphate. Additional inactive ingredients for the 500 mg tablet include macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide. Additional inactive ingredients for the 1000 mg tablet include iron oxide yellow, macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70756-704-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70756-704-60) </PackageDescription>
<NDC11Code>70756-0704-60</NDC11Code>
<ProductNDC>70756-704</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212284</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran and acetonitrile slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) Type A, microcrystalline cellulose, polysorbate 80, sodium hydroxide and sodium lauryl sulphate. Additional inactive ingredients for the 500 mg tablet include macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide. Additional inactive ingredients for the 1000 mg tablet include iron oxide yellow, macrogol/PEG 4000, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70756-811-65</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70756-811-65) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>70756-0811-65</NDC11Code>
<ProductNDC>70756-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170714</StartMarketingDate>
<EndMarketingDate>20210630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207741</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC],Polyenes [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170714</StartMarketingDatePackage>
<EndMarketingDatePackage>20210630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70756-815-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70756-815-60) </PackageDescription>
<NDC11Code>70756-0815-60</NDC11Code>
<ProductNDC>70756-815</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211724</ApplicationNumber>
<LabelerName>Lifestar Pharma 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>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1) perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1) treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1) Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated. (1.2) treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. (1.2) Gastric, Esophageal, or Gastroesophageal Junction Cancer treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (1.3) treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. (1.3) Pancreatic Cancer adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. (1.4).</IndicationAndUsage>
<Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N- [(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine Tablets, USP are supplied as biconvex, oblong film-coated tablets for oral use. Each light peach- colored tablet debossed with ‘C150’ on one side and plain on other side contains 150 mg of capecitabine USP and each peach colored tablet debossed with ‘C500’ on one side and plain on other side contains 500 mg of capecitabine USP. The inactive ingredients in capecitabine include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate. The peach or light peach film coating contains hydroxypropyl methylcellulose, polyethylene glycol, red iron oxides, synthetic yellow, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>25000-608-06</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-608-06) </PackageDescription>
<NDC11Code>25000-0608-06</NDC11Code>
<ProductNDC>25000-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090723</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive Ingredients include sugar spheres (contains sugar and corn starch), hypromellose, glycine, sucrose, talc, hypromellose phthalate, triethyl citrate, gelatin, titanium dioxide, FD&C Blue 2, sodium lauryl sulfate, shellac and iron oxide yellow. The 20 mg capsules also contain black iron oxide and potassium hydroxide. The 60 mg capsules also contain potassium hydroxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>45963-608-60</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (45963-608-60) > 100 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>45963-0608-60</NDC11Code>
<ProductNDC>45963-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epirubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Epirubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065445</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>EPIRUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111128</StartMarketingDatePackage>
<EndMarketingDatePackage>20201031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49999-608-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49999-608-60)</PackageDescription>
<NDC11Code>49999-0608-60</NDC11Code>
<ProductNDC>49999-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040409</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-03-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>53489-608-06</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (53489-608-06)</PackageDescription>
<NDC11Code>53489-0608-06</NDC11Code>
<ProductNDC>53489-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077520</ApplicationNumber>
<LabelerName>Mutual Pharmaceutical Company, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principle metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β, 8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg, and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: butylated hydroxyanisole (BHA), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Additionally, lovastatin 10 mg contains pigment blend light orange, lovastatin 20 mg contains FD&C Blue #2 Aluminum Lake, and lovastatin 40 mg contains Lake blend green.</Description>
</NDC>
<NDC>
<NDCCode>55111-608-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (55111-608-60)</PackageDescription>
<NDC11Code>55111-0608-60</NDC11Code>
<ProductNDC>55111-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090723</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58411-608-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-608-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0608-60</NDC11Code>
<ProductNDC>58411-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>5c1 Nutmeg</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>2.827; 1.542</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-608-01</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (58602-608-01) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>58602-0608-01</NDC11Code>
<ProductNDC>58602-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil 5% (for Men)</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218616</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-608-02</NDCCode>
<PackageDescription>2 CAN in 1 CARTON (58602-608-02) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>58602-0608-02</NDC11Code>
<ProductNDC>58602-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil 5% (for Men)</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218616</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-608-03</NDCCode>
<PackageDescription>3 CAN in 1 CARTON (58602-608-03) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>58602-0608-03</NDC11Code>
<ProductNDC>58602-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil 5% (for Men)</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218616</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-608-04</NDCCode>
<PackageDescription>4 CAN in 1 CARTON (58602-608-04) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>58602-0608-04</NDC11Code>
<ProductNDC>58602-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil 5% (for Men)</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218616</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-608-05</NDCCode>
<PackageDescription>6 CAN in 1 CARTON (58602-608-05) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>58602-0608-05</NDC11Code>
<ProductNDC>58602-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil 5% (for Men)</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218616</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58980-608-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (58980-608-60) > 177.42 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58980-0608-60</NDC11Code>
<ProductNDC>58980-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Urea</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100520</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharmaceuticals, Inc</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>61919-608-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-608-60) </PackageDescription>
<NDC11Code>61919-0608-60</NDC11Code>
<ProductNDC>61919-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<ProprietaryNameSuffix>E/r</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075492</ApplicationNumber>
<LabelerName>DIRECTRX</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets and other treatment options before deciding to use Diclofenac Sodium Extended-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac Sodium Extended-release Tablets are indicated. For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac Sodium Extended-release Tablets are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. [Chemical Structure]. Each extended-release tablet for oral administration contains 100 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D & C Red # 27 (phloxine aluminum lake), hydroxyethyl cellulose, hypromellose, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>65841-608-14</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (65841-608-14) </PackageDescription>
<NDC11Code>65841-0608-14</NDC11Code>
<ProductNDC>65841-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079017</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66215-608-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (66215-608-06) / 60 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>66215-0608-06</NDC11Code>
<ProductNDC>66215-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uptravi</ProprietaryName>
<NonProprietaryName>Selexipag</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207947</ApplicationNumber>
<LabelerName>Actelion Pharmaceuticals US, Inc.</LabelerName>
<SubstanceName>SELEXIPAG</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): 1 In adults to delay disease progression and reduce the risk of hospitalization for PAH. (1.1), 2 In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. (1.1).</IndicationAndUsage>
<Description>UPTRAVI contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide. It has a molecular formula of C26H32N4O4S and a molecular weight of 496.62. Selexipag has the following structural formula. Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. UPTRAVI® (selexipag) tablets: depending on the dose strength, each round film-coated tablet for oral administration contains 100, 150, 200, 400, 600, 800, 1,000, 1,200, 1,400, or 1,600 mcg of selexipag. The tablets include the following inactive ingredients: corn starch, D-mannitol, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, and magnesium stearate. The tablets are film coated with a coating material containing carnauba wax, hypromellose, propylene glycol, titanium dioxide, along with mixtures of iron oxide black, iron oxide red and/or iron oxide yellow. The coating material of the 100 mcg and 150 mcg tablets also contains talc. UPTRAVI® (selexipag) for injection: contains 1,800 mcg of selexipag per vial. UPTRAVI for injection includes the following inactive ingredients: glycine (180 mg), phosphoric acid (3.53 mg), polysorbate 20 (10.8 mg) and sodium hydroxide (for pH adjustment). UPTRAVI for injection is provided in 10 mL Type I clear glass vials closed by a stopper and tear-off aluminum seal.</Description>
</NDC>
<NDC>
<NDCCode>66267-608-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (66267-608-60) </PackageDescription>
<NDC11Code>66267-0608-60</NDC11Code>
<ProductNDC>66267-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071141</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66336-608-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (66336-608-60)</PackageDescription>
<NDC11Code>66336-0608-60</NDC11Code>
<ProductNDC>66336-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Misoprostol</ProprietaryName>
<NonProprietaryName>Misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091227</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019268</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>MISOPROSTOL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.</IndicationAndUsage>
<Description>Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±). Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>70445-608-03</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (70445-608-03) </PackageDescription>
<NDC11Code>70445-0608-03</NDC11Code>
<ProductNDC>70445-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scented Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Scented Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240820</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Beacon Promotions, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>63.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-608-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-608-60) </PackageDescription>
<NDC11Code>71205-0608-60</NDC11Code>
<ProductNDC>71205-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207799</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injuryPediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) contain red iron oxide, yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71610-608-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-608-60) </PackageDescription>
<NDC11Code>71610-0608-60</NDC11Code>
<ProductNDC>71610-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202330</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
</NDCList>