{
"NDC": [
{
"NDCCode": "61269-381-12",
"PackageDescription": "10 BLISTER PACK in 1 BOX (61269-381-12) / 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "61269-0381-12",
"ProductNDC": "61269-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pylera",
"NonProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole, And Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050786",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "140; 125; 125",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250818",
"SamplePackage": "N",
"Description": "PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg."
},
{
"NDCCode": "61269-380-12",
"PackageDescription": "10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "61269-0380-12",
"ProductNDC": "61269-380",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pylera",
"NonProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole, And Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050786",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "140; 125; 125",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20231001",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "PYLERA is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline,- a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg."
},
{
"NDCCode": "61269-385-12",
"PackageDescription": "1 BLISTER PACK in 1 BOX (61269-385-12) / 120 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "61269-0385-12",
"ProductNDC": "61269-385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole, And Tetracycline Hydrochloride",
"NonProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole, And Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230731",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050786",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "140; 125; 125",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230731",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline,- a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules and other antibacterial drugs, Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg."
},
{
"NDCCode": "61269-386-12",
"PackageDescription": "10 BLISTER PACK in 1 BOX (61269-386-12) / 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "61269-0386-12",
"ProductNDC": "61269-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride",
"NonProprietaryName": "Bismuth Subcitrate Potassium, Metronidazole And Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050786",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "140; 125; 125",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"Description": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg."
},
{
"NDCCode": "61269-475-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12) ",
"NDC11Code": "61269-0475-12",
"ProductNDC": "61269-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xeloda",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020896",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980430",
"SamplePackage": "N",
"IndicationAndUsage": "XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).",
"Description": "Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C15H22FN3O6 and 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 20°C. XELODA (capecitabine) is supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides."
},
{
"NDCCode": "61269-518-12",
"PackageDescription": "1 INHALER in 1 CARTON (61269-518-12) / 120 AEROSOL, POWDER in 1 INHALER",
"NDC11Code": "61269-0518-12",
"ProductNDC": "61269-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pulmicort",
"ProprietaryNameSuffix": "Flexhaler",
"NonProprietaryName": "Budesonide",
"DosageFormName": "AEROSOL, POWDER",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070319",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021949",
"LabelerName": "H2-Pharma LLC",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "180",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070319",
"SamplePackage": "N",
"IndicationAndUsage": "PULMICORT FLEXHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older (1) .",
"Description": "Budesonide, the active component of PULMICORT FLEXHALER, is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. PULMICORT FLEXHALER is an inhalation-driven multi-dose dry powder inhaler containing a formulation of 1 mg per actuation of micronized budesonide and micronized lactose monohydrate which contains trace levels of milk proteins [see Contraindications (4), Adverse Reactions (6.2)]. Each actuation of PULMICORT FLEXHALER 180 mcg delivers 160 mcg budesonide from the mouthpiece and each actuation of PULMICORT FLEXHALER 90 mcg delivers 80 mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec). Each PULMICORT FLEXHALER 180 mcg contains 120 actuations and each PULMICORT FLEXHALER 90 mcg contains 60 actuations. In vitro testing has shown that the dose delivery for PULMICORT FLEXHALER is dependent on airflow through the device, as evidenced by a decrease in the fine particle dose at a flow rate of 30 L/min to a value that is approximately 40-50% of that produced at 60 L/min. At a flow rate of 40 L/min, the fine particle dose is approximately 70% of that produced at 60 L/min. Patient factors such as inspiratory flow rates will also affect the dose delivered to the lungs of patients in actual use [see Patient Information and Instructions for Use]. In asthmatic children age 6 to 17 (N=516, FEV1 2.29 [0.97– 4.28]) peak inspiratory flow (PIF) through PULMICORT FLEXHALER was 72.5 [19.1 – 103.6] L/min). Inspiratory flows were not measured in the adult pivotal study. Patients should be carefully instructed on the use of this drug product to assure optimal dose delivery."
},
{
"NDCCode": "37205-381-53",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (37205-381-53) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "37205-0381-53",
"ProductNDC": "37205-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20040225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075990",
"LabelerName": "Cardinal Health",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "37205-381-67",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (37205-381-67) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "37205-0381-67",
"ProductNDC": "37205-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20040225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075990",
"LabelerName": "Cardinal Health",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49483-381-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-381-12) ",
"NDC11Code": "49483-0381-12",
"ProductNDC": "49483-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Low Dose Aspirin",
"ProprietaryNameSuffix": "Enteric Safety Coated",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100810",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Time-Cap Labs, Inc",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181217",
"SamplePackage": "N"
},
{
"NDCCode": "57896-381-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (57896-381-12) ",
"NDC11Code": "57896-0381-12",
"ProductNDC": "57896-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-diarrheal",
"NonProprietaryName": "Loperamide Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076497",
"LabelerName": "Geri-Care Pharmaceutical Corp",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20060201",
"SamplePackage": "N"
},
{
"NDCCode": "68428-381-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-381-12) ",
"NDC11Code": "68428-0381-12",
"ProductNDC": "68428-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Carbonicum",
"NonProprietaryName": "Ferrous Carbonate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERROUS CARBONATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20110511",
"SamplePackage": "N"
},
{
"NDCCode": "84126-381-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (84126-381-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "84126-0381-24",
"ProductNDC": "84126-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Nyquil",
"ProprietaryNameSuffix": "Allergy",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "87551-381-12",
"PackageDescription": "25 g in 1 BAG (87551-381-12) ",
"NDC11Code": "87551-0381-12",
"ProductNDC": "87551-381",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Thymosin Alpha-1 Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pure Peptide Pharmaceuticals Inc.",
"SubstanceName": "THYMALFASIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-06-22",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-MAY-26"
},
{
"NDCCode": "61269-480-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "61269-0480-60",
"ProductNDC": "61269-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valcyte",
"NonProprietaryName": "Valganciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021304",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010329",
"SamplePackage": "N",
"IndicationAndUsage": "VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.",
"Description": "VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir."
},
{
"NDCCode": "61269-485-10",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "61269-0485-10",
"ProductNDC": "61269-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valcyte",
"NonProprietaryName": "Valganciclovir Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090828",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022257",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090828",
"SamplePackage": "N",
"IndicationAndUsage": "VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.",
"Description": "VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir."
},
{
"NDCCode": "61269-605-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (61269-605-10) ",
"NDC11Code": "61269-0605-10",
"ProductNDC": "61269-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100826",
"SamplePackage": "N",
"IndicationAndUsage": "Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).",
"Description": "Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "61269-610-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (61269-610-10) ",
"NDC11Code": "61269-0610-10",
"ProductNDC": "61269-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100904",
"SamplePackage": "N",
"IndicationAndUsage": "Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).",
"Description": "Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "61269-620-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (61269-620-10) ",
"NDC11Code": "61269-0620-10",
"ProductNDC": "61269-620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klonopin",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19750602",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017533",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100826",
"SamplePackage": "N",
"IndicationAndUsage": "Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).",
"Description": "Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "61269-750-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (61269-750-10) ",
"NDC11Code": "61269-0750-10",
"ProductNDC": "61269-750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vesanoid",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020438",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240201",
"SamplePackage": "N",
"IndicationAndUsage": "VESANOID is indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.",
"Description": "Tretinoin is a retinoid. The chemical name is all-trans retinoic acid. The molecular formula is C20H28O2 and the molecular weight is 300.44 g/mol. The structural formula is. It is a yellow to light orange, crystalline powder with melting point at about 182°C (with decomposition). Tretinoin is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in ethanol (96%). VESANOID (tretinoin) is available as capsules containing 10 mg tretinoin for oral use. Each capsule also contains yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil and refined soya-bean oil. The capsule shell contains gelatin, glycerol (85%), dry substance of Karion 83, titanium dioxide, yellow iron oxide, red iron oxide and traces of monogramming ink."
},
{
"NDCCode": "61269-850-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (61269-850-10) ",
"NDC11Code": "61269-0850-10",
"ProductNDC": "61269-850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240201",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020438",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "TRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240201",
"SamplePackage": "N",
"IndicationAndUsage": "TRETINOIN is indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.",
"Description": "Tretinoin is a retinoid. The chemical name is all-trans retinoic acid. The molecular formula is C20H28O2 and the molecular weight is 300.44 g/mol. The structural formula is. It is a yellow to light orange, crystalline powder with melting point at about 182°C (with decomposition). Tretinoin is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in ethanol (96%). TRETINOIN is available as capsules containing 10 mg tretinoin for oral use. Each capsule also contains yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil and refined soya-bean oil. The capsule shell contains gelatin, glycerol (85%), dry substance of Karion 83, titanium dioxide, yellow iron oxide, red iron oxide and traces of monogramming ink."
},
{
"NDCCode": "0480-1232-08",
"PackageDescription": "1 KIT in 1 CARTON (0480-1232-08) * 2 mL in 1 VIAL (0480-9733-01) * 2 mL in 1 SYRINGE (0480-1200-21) ",
"NDC11Code": "00480-1232-08",
"ProductNDC": "0480-1232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"StartMarketingDate": "20231211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214068",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231211",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "0480-1342-08",
"PackageDescription": "1 KIT in 1 CARTON (0480-1342-08) * 2 mL in 1 VIAL (0480-9734-01) * 2 mL in 1 SYRINGE (0480-1200-21) ",
"NDC11Code": "00480-1342-08",
"ProductNDC": "0480-1342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"StartMarketingDate": "20231211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214068",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231211",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "0480-1453-08",
"PackageDescription": "1 KIT in 1 CARTON (0480-1453-08) * 2 mL in 1 VIAL (0480-9735-01) * 2 mL in 1 SYRINGE (0480-1200-21) ",
"NDC11Code": "00480-1453-08",
"ProductNDC": "0480-1453",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"StartMarketingDate": "20231211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214068",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231211",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "0480-1554-08",
"PackageDescription": "1 KIT in 1 CARTON (0480-1554-08) * 2 mL in 1 VIAL (0480-9732-01) * 2 mL in 1 SYRINGE (0480-1200-21) ",
"NDC11Code": "00480-1554-08",
"ProductNDC": "0480-1554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"StartMarketingDate": "20231211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214068",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231211",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).",
"Description": "Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration)."
},
{
"NDCCode": "0615-8338-39",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (0615-8338-39) ",
"NDC11Code": "00615-8338-39",
"ProductNDC": "0615-8338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191209",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202240",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200304",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).",
"Description": "Celecoxib capsules is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib include: black iron oxide, croscarmellose sodium, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, propylene glycol, shellac, sodium lauryl sulphate, titanium dioxide, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "0904-6502-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-6502-61) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00904-6502-61",
"ProductNDC": "0904-6502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150625",
"EndMarketingDate": "20251130",
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"ApplicationNumber": "ANDA204197",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "CELECOXIB",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
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"LastUpdate": "2025-12-01",
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"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, and 200 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38 g/mol. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is >3) and is soluble in methanol, acetone, ethanol, DMSO, ethyl acetate and methylene chloride. Celecoxib capsules for oral administration contain either 50 mg, 100 mg, or 200 mg of celecoxib, together with inactive ingredients including: crospovidone, magnesium stearate, povidone, sodium lauryl sulphate. The capsule shell contains gelatin and titanium dioxide. The capsule imprinting ink for the 50 mg strength contains FD&C Red #40 Aluminum Lake, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. The capsule imprinting ink for the 100 mg strength contains FD&C Blue #2 Aluminum Lake, propylene glycol, shellac and strong ammonia solution. The capsule imprinting ink for the 200 mg strength contains dimethicone, iron oxide yellow, propylene glycol, shellac and strong ammonia solution."
},
{
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"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains propylene glycol, red iron oxide and shellac. 100 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol and shellac. 200 mg capsule contains propylene glycol, shellac and yellow iron oxide. 400 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol, shellac, titanium dioxide and yellow iron oxide."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains propylene glycol, red iron oxide and shellac. 100 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol and shellac. 200 mg capsule contains propylene glycol, shellac and yellow iron oxide. 400 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol, shellac, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "10812-381-01",
"PackageDescription": "5.5 g in 1 CASE (10812-381-01)",
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"ProductNDC": "10812-381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Mineral Sheers",
"ProprietaryNameSuffix": "Spf20 - Classic Ivory 10",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110620",
"EndMarketingDate": "20160801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "TITANIUM DIOXIDE",
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"LastUpdate": "2016-12-02"
},
{
"NDCCode": "13668-307-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (13668-307-01) ",
"NDC11Code": "13668-0307-01",
"ProductNDC": "13668-307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207677",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib, USP is a white or almost white, crystalline powder with a pKa of 11. Celecoxib is freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate DCL 11, magnesium stearate, povidone (K 30) and sodium lauryl sulfate. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 50 mg capsule shell contain iron oxide red, 100 mg capsule shell contain FD&C blue 1 and FD&C red 40, 200 mg capsule shell contain iron oxide yellow and 400 mg capsule shell contain FD&C blue 2 and iron oxide yellow. The imprinting ink contains iron oxide black, propylene glycol, potassium hydroxide, povidone, shellac, sodium hydroxide and titanium dioxide."
}
]
}
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<Description>PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg.</Description>
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<Description>Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg.</Description>
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<LastUpdate>2026-04-15</LastUpdate>
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<Description>Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: 1 bismuth subcitrate potassium, 140 mg, 2 metronidazole, 125 mg, 3 smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg.</Description>
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<NDC>
<NDCCode>61269-475-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12) </PackageDescription>
<NDC11Code>61269-0475-12</NDC11Code>
<ProductNDC>61269-475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xeloda</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020896</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).</IndicationAndUsage>
<Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C15H22FN3O6 and 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 20°C. XELODA (capecitabine) is supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.</Description>
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<NDC>
<NDCCode>61269-518-12</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (61269-518-12) / 120 AEROSOL, POWDER in 1 INHALER</PackageDescription>
<NDC11Code>61269-0518-12</NDC11Code>
<ProductNDC>61269-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pulmicort</ProprietaryName>
<ProprietaryNameSuffix>Flexhaler</ProprietaryNameSuffix>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>AEROSOL, POWDER</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20070319</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021949</ApplicationNumber>
<LabelerName>H2-Pharma LLC</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PULMICORT FLEXHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older (1) .</IndicationAndUsage>
<Description>Budesonide, the active component of PULMICORT FLEXHALER, is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. PULMICORT FLEXHALER is an inhalation-driven multi-dose dry powder inhaler containing a formulation of 1 mg per actuation of micronized budesonide and micronized lactose monohydrate which contains trace levels of milk proteins [see Contraindications (4), Adverse Reactions (6.2)]. Each actuation of PULMICORT FLEXHALER 180 mcg delivers 160 mcg budesonide from the mouthpiece and each actuation of PULMICORT FLEXHALER 90 mcg delivers 80 mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec). Each PULMICORT FLEXHALER 180 mcg contains 120 actuations and each PULMICORT FLEXHALER 90 mcg contains 60 actuations. In vitro testing has shown that the dose delivery for PULMICORT FLEXHALER is dependent on airflow through the device, as evidenced by a decrease in the fine particle dose at a flow rate of 30 L/min to a value that is approximately 40-50% of that produced at 60 L/min. At a flow rate of 40 L/min, the fine particle dose is approximately 70% of that produced at 60 L/min. Patient factors such as inspiratory flow rates will also affect the dose delivered to the lungs of patients in actual use [see Patient Information and Instructions for Use]. In asthmatic children age 6 to 17 (N=516, FEV1 2.29 [0.97– 4.28]) peak inspiratory flow (PIF) through PULMICORT FLEXHALER was 72.5 [19.1 – 103.6] L/min). Inspiratory flows were not measured in the adult pivotal study. Patients should be carefully instructed on the use of this drug product to assure optimal dose delivery.</Description>
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<PackageDescription>1 BLISTER PACK in 1 CARTON (37205-381-53) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075990</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37205-381-67</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (37205-381-67) > 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37205-0381-67</NDC11Code>
<ProductNDC>37205-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075990</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49483-381-12</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-381-12) </PackageDescription>
<NDC11Code>49483-0381-12</NDC11Code>
<ProductNDC>49483-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Low Dose Aspirin</ProprietaryName>
<ProprietaryNameSuffix>Enteric Safety Coated</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Time-Cap Labs, Inc</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57896-381-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (57896-381-12) </PackageDescription>
<NDC11Code>57896-0381-12</NDC11Code>
<ProductNDC>57896-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076497</ApplicationNumber>
<LabelerName>Geri-Care Pharmaceutical Corp</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-381-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-381-12) </PackageDescription>
<NDC11Code>68428-0381-12</NDC11Code>
<ProductNDC>68428-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Carbonicum</ProprietaryName>
<NonProprietaryName>Ferrous Carbonate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERROUS CARBONATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84126-381-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (84126-381-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>84126-0381-24</NDC11Code>
<ProductNDC>84126-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Nyquil</ProprietaryName>
<ProprietaryNameSuffix>Allergy</ProprietaryNameSuffix>
<NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87551-381-12</NDCCode>
<PackageDescription>25 g in 1 BAG (87551-381-12) </PackageDescription>
<NDC11Code>87551-0381-12</NDC11Code>
<ProductNDC>87551-381</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Thymosin Alpha-1 Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pure Peptide Pharmaceuticals Inc.</LabelerName>
<SubstanceName>THYMALFASIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-22</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61269-480-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>61269-0480-60</NDC11Code>
<ProductNDC>61269-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valcyte</ProprietaryName>
<NonProprietaryName>Valganciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021304</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
<Description>VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>61269-485-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>61269-0485-10</NDC11Code>
<ProductNDC>61269-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valcyte</ProprietaryName>
<NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090828</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022257</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
<Description>VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>61269-605-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (61269-605-10) </PackageDescription>
<NDC11Code>61269-0605-10</NDC11Code>
<ProductNDC>61269-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).</IndicationAndUsage>
<Description>Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>61269-610-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (61269-610-10) </PackageDescription>
<NDC11Code>61269-0610-10</NDC11Code>
<ProductNDC>61269-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).</IndicationAndUsage>
<Description>Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>61269-620-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (61269-620-10) </PackageDescription>
<NDC11Code>61269-0620-10</NDC11Code>
<ProductNDC>61269-620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klonopin</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750602</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017533</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).</IndicationAndUsage>
<Description>Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>61269-750-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (61269-750-10) </PackageDescription>
<NDC11Code>61269-0750-10</NDC11Code>
<ProductNDC>61269-750</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vesanoid</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020438</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VESANOID is indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.</IndicationAndUsage>
<Description>Tretinoin is a retinoid. The chemical name is all-trans retinoic acid. The molecular formula is C20H28O2 and the molecular weight is 300.44 g/mol. The structural formula is. It is a yellow to light orange, crystalline powder with melting point at about 182°C (with decomposition). Tretinoin is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in ethanol (96%). VESANOID (tretinoin) is available as capsules containing 10 mg tretinoin for oral use. Each capsule also contains yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil and refined soya-bean oil. The capsule shell contains gelatin, glycerol (85%), dry substance of Karion 83, titanium dioxide, yellow iron oxide, red iron oxide and traces of monogramming ink.</Description>
</NDC>
<NDC>
<NDCCode>61269-850-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (61269-850-10) </PackageDescription>
<NDC11Code>61269-0850-10</NDC11Code>
<ProductNDC>61269-850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240201</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020438</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRETINOIN is indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.</IndicationAndUsage>
<Description>Tretinoin is a retinoid. The chemical name is all-trans retinoic acid. The molecular formula is C20H28O2 and the molecular weight is 300.44 g/mol. The structural formula is. It is a yellow to light orange, crystalline powder with melting point at about 182°C (with decomposition). Tretinoin is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in ethanol (96%). TRETINOIN is available as capsules containing 10 mg tretinoin for oral use. Each capsule also contains yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil and refined soya-bean oil. The capsule shell contains gelatin, glycerol (85%), dry substance of Karion 83, titanium dioxide, yellow iron oxide, red iron oxide and traces of monogramming ink.</Description>
</NDC>
<NDC>
<NDCCode>0480-1232-08</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0480-1232-08) * 2 mL in 1 VIAL (0480-9733-01) * 2 mL in 1 SYRINGE (0480-1200-21) </PackageDescription>
<NDC11Code>00480-1232-08</NDC11Code>
<ProductNDC>0480-1232</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214068</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>0480-1342-08</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0480-1342-08) * 2 mL in 1 VIAL (0480-9734-01) * 2 mL in 1 SYRINGE (0480-1200-21) </PackageDescription>
<NDC11Code>00480-1342-08</NDC11Code>
<ProductNDC>0480-1342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214068</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>0480-1453-08</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0480-1453-08) * 2 mL in 1 VIAL (0480-9735-01) * 2 mL in 1 SYRINGE (0480-1200-21) </PackageDescription>
<NDC11Code>00480-1453-08</NDC11Code>
<ProductNDC>0480-1453</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214068</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>0480-1554-08</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0480-1554-08) * 2 mL in 1 VIAL (0480-9732-01) * 2 mL in 1 SYRINGE (0480-1200-21) </PackageDescription>
<NDC11Code>00480-1554-08</NDC11Code>
<ProductNDC>0480-1554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214068</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone for Extended-Release Injectable Suspension is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. (1.2).</IndicationAndUsage>
<Description>Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).</Description>
</NDC>
<NDC>
<NDCCode>0615-8338-39</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (0615-8338-39) </PackageDescription>
<NDC11Code>00615-8338-39</NDC11Code>
<ProductNDC>0615-8338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191209</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202240</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200304</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
<Description>Celecoxib capsules is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib include: black iron oxide, croscarmellose sodium, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, propylene glycol, shellac, sodium lauryl sulphate, titanium dioxide, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0904-6502-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-6502-61) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6502-61</NDC11Code>
<ProductNDC>0904-6502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150625</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204197</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150625</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, and 200 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38 g/mol. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is >3) and is soluble in methanol, acetone, ethanol, DMSO, ethyl acetate and methylene chloride. Celecoxib capsules for oral administration contain either 50 mg, 100 mg, or 200 mg of celecoxib, together with inactive ingredients including: crospovidone, magnesium stearate, povidone, sodium lauryl sulphate. The capsule shell contains gelatin and titanium dioxide. The capsule imprinting ink for the 50 mg strength contains FD&C Red #40 Aluminum Lake, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. The capsule imprinting ink for the 100 mg strength contains FD&C Blue #2 Aluminum Lake, propylene glycol, shellac and strong ammonia solution. The capsule imprinting ink for the 200 mg strength contains dimethicone, iron oxide yellow, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0904-7550-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7550-61) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7550-61</NDC11Code>
<ProductNDC>0904-7550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains propylene glycol, red iron oxide and shellac. 100 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol and shellac. 200 mg capsule contains propylene glycol, shellac and yellow iron oxide. 400 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol, shellac, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0904-7551-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7551-61) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7551-61</NDC11Code>
<ProductNDC>0904-7551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains propylene glycol, red iron oxide and shellac. 100 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol and shellac. 200 mg capsule contains propylene glycol, shellac and yellow iron oxide. 400 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol, shellac, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>10812-381-01</NDCCode>
<PackageDescription>5.5 g in 1 CASE (10812-381-01)</PackageDescription>
<NDC11Code>10812-0381-01</NDC11Code>
<ProductNDC>10812-381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Mineral Sheers</ProprietaryName>
<ProprietaryNameSuffix>Spf20 - Classic Ivory 10</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<EndMarketingDate>20160801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>13668-307-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (13668-307-01) </PackageDescription>
<NDC11Code>13668-0307-01</NDC11Code>
<ProductNDC>13668-307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207677</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib, USP is a white or almost white, crystalline powder with a pKa of 11. Celecoxib is freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate DCL 11, magnesium stearate, povidone (K 30) and sodium lauryl sulfate. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 50 mg capsule shell contain iron oxide red, 100 mg capsule shell contain FD&C blue 1 and FD&C red 40, 200 mg capsule shell contain iron oxide yellow and 400 mg capsule shell contain FD&C blue 2 and iron oxide yellow. The imprinting ink contains iron oxide black, propylene glycol, potassium hydroxide, povidone, shellac, sodium hydroxide and titanium dioxide.</Description>
</NDC>
</NDCList>