{
"NDC": [
{
"NDCCode": "53002-0550-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-0550-3) ",
"NDC11Code": "53002-0550-03",
"ProductNDC": "53002-0550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terbinafine",
"NonProprietaryName": "Terbinafine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078297",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "TERBINAFINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.",
"Description": "Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride USP.Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The molecular formula C21H26ClN with a molecular weight of 327.90, and the following structural formula. Terbinafine hydrochloride USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.Each tablet contains:Active Ingredient: Terbinafine hydrochloride USP (equivalent to 250 mg of terbinafine)Inactive Ingredients: Microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, hypromellose, and magnesium stearate."
},
{
"NDCCode": "15631-0550-3",
"PackageDescription": "100 TABLET in 1 CONTAINER (15631-0550-3)",
"NDC11Code": "15631-0550-03",
"ProductNDC": "15631-0550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Sulphurica",
"NonProprietaryName": "Calcarea Sulphurica",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151207",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "CALCIUM SULFATE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0550-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0550-3) ",
"NDC11Code": "37662-0550-03",
"ProductNDC": "37662-0550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Conium Maculatum",
"NonProprietaryName": "Conium Maculatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220614",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CONIUM MACULATUM FLOWERING TOP",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220614",
"SamplePackage": "N"
},
{
"NDCCode": "38779-0550-3",
"PackageDescription": "5000 g in 1 PAIL (38779-0550-3)",
"NDC11Code": "38779-0550-03",
"ProductNDC": "38779-0550",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sulfadiazine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120416",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "SULFADIAZINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "63190-0550-3",
"PackageDescription": "30 kg in 1 DRUM (63190-0550-3)",
"NDC11Code": "63190-0550-03",
"ProductNDC": "63190-0550",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gestodene",
"DosageFormName": "POWDER",
"StartMarketingDate": "20141231",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Industriale Chimica s.r.l.",
"SubstanceName": "GESTODENE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2020-12-17",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "69968-0550-3",
"PackageDescription": "3700 mL in 1 BOTTLE (69968-0550-3) ",
"NDC11Code": "69968-0550-03",
"ProductNDC": "69968-0550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Listerine Cool Mint Antiseptic",
"NonProprietaryName": "Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, And Thymol",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181203",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent and reduce: 1 Plaque, 2 Gingivitis."
},
{
"NDCCode": "71335-0550-3",
"PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0550-3) ",
"NDC11Code": "71335-0550-03",
"ProductNDC": "71335-0550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dok",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150228",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150713",
"SamplePackage": "N"
},
{
"NDCCode": "0069-0550-38",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0069-0550-38) ",
"NDC11Code": "00069-0550-38",
"ProductNDC": "0069-0550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sutent",
"NonProprietaryName": "Sunitinib Malate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021938",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "SUNITINIB MALATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060126",
"SamplePackage": "N",
"IndicationAndUsage": "SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
"Description": "Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide."
},
{
"NDCCode": "0597-0555-80",
"PackageDescription": "2 KIT in 1 CARTON (0597-0555-80) / 1 KIT in 1 KIT * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET * 1 SYRINGE in 1 TRAY (0597-0550-06) / .4 mL in 1 SYRINGE",
"NDC11Code": "00597-0555-80",
"ProductNDC": "0597-0555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab-adbm",
"NonProprietaryName": "Adalimumab-adbm",
"DosageFormName": "KIT",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761058",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP."
},
{
"NDCCode": "10122-550-28",
"PackageDescription": "4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "10122-0550-28",
"ProductNDC": "10122-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycapssa",
"NonProprietaryName": "Octreotide",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208232",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "OCTREOTIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200706",
"SamplePackage": "N",
"IndicationAndUsage": "MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.",
"Description": "MYCAPSSA delayed release capsules contain octreotide acetate, a somatostatin analog. Octreotide is known chemically as L-cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 (free peptide, C49H66N10O10S2) and its amino acid sequence is. MYCAPSSA (octreotide) delayed-release capsules are enteric-coated capsules for oral use. Each capsule contains 20 mg of octreotide (provided as octreotide acetate). Octreotide is present as a salt with 1.4 to 2.5 molar equivalents of acetate. The capsules contain the following inactive ingredients: polyvinylpyrrolidone (PVP-12), sodium caprylate, magnesium chloride, polysorbate 80, glyceryl monocaprylate, glyceryl tricaprylate, gelatin, gelatin capsules, and Acryl-EZE® (methacrylate). The capsule is printed with \"OT 20\" in Opacode® black ink."
},
{
"NDCCode": "13668-550-94",
"PackageDescription": "30 GRANULE, DELAYED RELEASE in 1 CARTON (13668-550-94) ",
"NDC11Code": "13668-0550-94",
"ProductNDC": "13668-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"ProprietaryNameSuffix": "For Delayed-release Oral Suspension",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "GRANULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212651",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250305",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium for delayed-release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed-release oral suspension is indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg with molecular weight of 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. The stability of esomeprazole magnesium USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium for delayed-release oral suspension is supplied in packets. Each packet of Esomeprazole magnesium for delayed-release oral suspension contains esomeprazole magnesium USP equivalent to esomeprazole 2.5 mg, 5 mg, 20 mg, or 40 mg, in the form of enteric-coated pellets. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of enteric-coated pellets, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.588 mg esomeprazole magnesium USP), 2 5 mg esomeprazole (equivalent to 5.176 mg esomeprazole magnesium USP), 3 20 mg esomeprazole (equivalent to 20.706 mg esomeprazole magnesium USP), 4 40 mg esomeprazole (equivalent to 41.411 mg esomeprazole magnesium USP)."
},
{
"NDCCode": "16714-550-01",
"PackageDescription": "60 TABLET in 1 BOTTLE (16714-550-01) ",
"NDC11Code": "16714-0550-01",
"ProductNDC": "16714-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208308",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 1 month of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "16729-550-10",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16729-550-10) ",
"NDC11Code": "16729-0550-10",
"ProductNDC": "16729-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate",
"NonProprietaryName": "Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209069",
"LabelerName": "Accord Healthcare, Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
"StrengthNumber": "8; 2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "Buprenorphine and Naloxone Sublingual Tablets, USP are uncoated white to off-white, round biconvex tablets, debossed with an alpha-numeric imprint identifying the product and strength on one side, and plain on the other. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). They are intended for sublingual administration and are available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains citric acid anhydrous, crospovidone, lactose monohydrate, magnesium stearate, mannitol, corn syrup solids, modified food starch, natural lemon flavor, pregelatinized starch (maize), povidone, sodium citrate dihydrate, and sucralose. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4, 5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4HCl2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "17139-550-30",
"PackageDescription": "30 PACKET in 1 CARTON (17139-550-30) / 5 g in 1 PACKET",
"NDC11Code": "17139-0550-30",
"ProductNDC": "17139-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Androgel",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20230217",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021015",
"LabelerName": "ASCEND Therapeutics U.S., LLC",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "AndroGel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .",
"Description": "AndroGel 1% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1% is available in a metered-dose pump or unit dose packets. The active pharmacologic ingredient in AndroGel 1% is testosterone, an androgen. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active."
},
{
"NDCCode": "23155-550-31",
"PackageDescription": "1 VIAL in 1 CARTON (23155-550-31) / 20 mL in 1 VIAL",
"NDC11Code": "23155-0550-31",
"ProductNDC": "23155-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20151109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090648",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151109",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1), 2 postoperative nausea and/or vomiting. (1.2).",
"Description": "The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2 mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Each 1 mL of aqueous solution in the 20 mL multi-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0."
},
{
"NDCCode": "24338-550-01",
"PackageDescription": "1 KIT in 1 KIT (24338-550-01) ",
"NDC11Code": "24338-0550-01",
"ProductNDC": "24338-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suflave",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution",
"DosageFormName": "KIT",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215344",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.",
"Description": "SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative and is provided in two bottles and two flavor enhancing packets for oral solution. The active ingredients contained in SUFLAVE are provided in Table 3. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride, plus the following excipients: advantame, lemon-lime flavor, and neotame. Each flavor enhancing packet contains anhydrous citric acid, colloidal silicon dioxide, malic acid, and sucralose. Each dose of reconstituted oral solution is one liter of slightly hazy to hazy liquid that contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride and the following excipients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose."
},
{
"NDCCode": "28595-550-12",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (28595-550-12) / 200 SPRAY in 1 BOTTLE, SPRAY",
"NDC11Code": "28595-0550-12",
"ProductNDC": "28595-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrolingual",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018705",
"LabelerName": "Allegis Pharmaceuticals, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190701",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C 3H 5N 3O 9). The compound has a molecular weight of 227.09. The chemical structure is:. CH 2–ONO 2. |. CH–ONO 2. |. CH 2–ONO 2. Nitrolingual Pumpspray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil, sodium lactate, lactic acid."
},
{
"NDCCode": "28595-550-49",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (28595-550-49) / 60 SPRAY in 1 BOTTLE, SPRAY",
"NDC11Code": "28595-0550-49",
"ProductNDC": "28595-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrolingual",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018705",
"LabelerName": "Allegis Pharmaceuticals, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190701",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C 3H 5N 3O 9). The compound has a molecular weight of 227.09. The chemical structure is:. CH 2–ONO 2. |. CH–ONO 2. |. CH 2–ONO 2. Nitrolingual Pumpspray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil, sodium lactate, lactic acid."
},
{
"NDCCode": "31722-550-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-550-30) ",
"NDC11Code": "31722-0550-30",
"ProductNDC": "31722-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217443",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate capsules are an extended-release capsule. Topiramate extended-release capsules, USP contain the following inactive ingredients. hydroxy propyl methyl cellulose, sugar spheres, starch (maze), sucrose, talc, ethylcellulose, ammonium hydroxide, medium chain triglycerides, oleic acid, polyvinyl alcohol, lecithin, xanthan gum, polyethylene glycol, gelatin, titanium dioxide and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows:25 mg: FD&C yellow 6, D&C yellow 10, FD&C blue 1 and iron oxide yellow50 mg: FD&C yellow 6, FD&C blue 1 and iron oxide yellow100 mg: FD&C yellow 6 and FD&C blue 1200 mg: FD&C blue 1 and FD&C yellow 6. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "33261-550-06",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (33261-550-06)",
"NDC11Code": "33261-0550-06",
"ProductNDC": "33261-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040268",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide."
},
{
"NDCCode": "33261-550-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-550-30)",
"NDC11Code": "33261-0550-30",
"ProductNDC": "33261-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040268",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide."
},
{
"NDCCode": "33342-550-09",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (33342-550-09) ",
"NDC11Code": "33342-0550-09",
"ProductNDC": "33342-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nintedanib Esylate",
"NonProprietaryName": "Nintedanib Esylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219926",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "NINTEDANIB ESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N",
"IndicationAndUsage": "Nintedanib capsules are kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) (1.1) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (1.2).",
"Description": "Nintedanib capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-,methyl ester, (3Z)-, ethanesulfonate (1:1). Its structural fomula is. Nintedanib esylate is a Greenish yellow to bright yellow powder with an empirical formula of C33H39N5O7S and a molecular weight of 649.76 g/mol. Nintedanib capsules for oral administration are available in 2 dose strengths containing 100 mg or 150 mg of nintedanib (equivalent to 120.40 mg or 180.60 mg nintedanib esylate respectively). The inactive ingredients of nintedanib capsules are the following: Fill Material: polyethylene glycol, caprylocaproyl polyoxyl-8 glycerides and triglycerides. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide, Imprinting Ink: shellac glaze, ferrosoferric oxide/black iron oxide, propylene glycol, ammonium hydroxide."
},
{
"NDCCode": "37012-550-30",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (37012-550-30) > 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "37012-0550-30",
"ProductNDC": "37012-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20100602",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Shopko Stores Operating Co., LLC.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for relief of: 1 bloating, 2 pressure, 3 fullness, 4 stuffed feeling commonly referred to as gas."
},
{
"NDCCode": "42195-550-14",
"PackageDescription": "14 CONTAINER in 1 CARTON (42195-550-14) / .25 mL in 1 CONTAINER",
"NDC11Code": "42195-0550-14",
"ProductNDC": "42195-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin Otic",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20120827",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021918",
"LabelerName": "Xspire Pharma, Llc",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/.25mL",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120827",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin Otic Solution is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosaor Staphylococcus aureus.",
"Description": "Ciprofloxacin Otic Solution 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin Otic Solution is a sterile, preservative-free solution for otic use. Each single use container of Ciprofloxacin Otic Solution delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH. Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17H 18FN 3O 3HClH 2O, and molecular weight is 385.82. The chemical structure of ciprofloxacin hydrochloride is."
},
{
"NDCCode": "42346-550-85",
"PackageDescription": "85 g in 1 TUBE (42346-550-85) ",
"NDC11Code": "42346-0550-85",
"ProductNDC": "42346-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothing Nerve Therapy",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Wise Consumer Products",
"SubstanceName": "MENTHOL",
"StrengthNumber": "1.3",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N"
},
{
"NDCCode": "42346-550-86",
"PackageDescription": "1 TUBE in 1 CARTON (42346-550-86) / 85 g in 1 TUBE",
"NDC11Code": "42346-0550-86",
"ProductNDC": "42346-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothing Nerve Therapy",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Wise Consumer Products",
"SubstanceName": "MENTHOL",
"StrengthNumber": "1.3",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251217",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains."
},
{
"NDCCode": "42346-550-87",
"PackageDescription": "2 TUBE in 1 CARTON (42346-550-87) / 85 g in 1 TUBE",
"NDC11Code": "42346-0550-87",
"ProductNDC": "42346-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothing Nerve Therapy",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Wise Consumer Products",
"SubstanceName": "MENTHOL",
"StrengthNumber": "1.3",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains."
},
{
"NDCCode": "42829-550-32",
"PackageDescription": "1 TUBE in 1 CARTON (42829-550-32) / 7 g in 1 TUBE",
"NDC11Code": "42829-0550-32",
"ProductNDC": "42829-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zilactin-b",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": ".1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251106",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves pain caused by: 1 canker sores, 2 minor mouth sores and gum irritations, 3 denture and brace pain."
},
{
"NDCCode": "43386-550-04",
"PackageDescription": "40 TABLET in 1 BOTTLE (43386-550-04) ",
"NDC11Code": "43386-0550-04",
"ProductNDC": "43386-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tinidazole",
"NonProprietaryName": "Tinidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202044",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "TINIDAZOLE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120430",
"SamplePackage": "N",
"IndicationAndUsage": "Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: 1 Trichomoniasis (1.1), 2 Giardiasis: in patients age 3 and older (1.2), 3 Amebiasis: in patients age 3 and older (1.3), 4 Bacterial Vaginosis: in adult women (1.4, 8.1).",
"Description": "Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure. Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include pregelatinized starch NF, croscarmellose sodium NF, magnesium stearate NF, microcrystalline cellulose NF, polyvinyl alcohol-part hydrolyzed USP, titanium dioxide USP, polyethylene glycol 3000 NF, talc USP, and FD&C red # 40 aluminum lake."
},
{
"NDCCode": "43598-550-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-550-01) ",
"NDC11Code": "43598-0550-01",
"ProductNDC": "43598-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20160617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206382",
"LabelerName": "Dr. Reddy�s Laboratories Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160617",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older. : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. ( 1.1) .",
"Description": "Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.1. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in anhydrous ethanol, practically insoluble in dilute hydrochloric acid and in water. The structural formula is:. Lamotrigine Orally Disintegrating Tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: amino methacrylate copolymer, aspartame, colloidal silicon dioxide, crospovidone, kollidon SR, magnesium stearate, mannitol, sucralose and artificial cherry flavor containing dextrose, corn starch, and tricalcium phosphate."
}
]
}
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<NDCList>
<NDC>
<NDCCode>53002-0550-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-0550-3) </PackageDescription>
<NDC11Code>53002-0550-03</NDC11Code>
<ProductNDC>53002-0550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terbinafine</ProprietaryName>
<NonProprietaryName>Terbinafine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078297</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TERBINAFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.</IndicationAndUsage>
<Description>Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride USP.Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The molecular formula C21H26ClN with a molecular weight of 327.90, and the following structural formula. Terbinafine hydrochloride USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.Each tablet contains:Active Ingredient: Terbinafine hydrochloride USP (equivalent to 250 mg of terbinafine)Inactive Ingredients: Microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, hypromellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>15631-0550-3</NDCCode>
<PackageDescription>100 TABLET in 1 CONTAINER (15631-0550-3)</PackageDescription>
<NDC11Code>15631-0550-03</NDC11Code>
<ProductNDC>15631-0550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Sulphurica</ProprietaryName>
<NonProprietaryName>Calcarea Sulphurica</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>CALCIUM SULFATE ANHYDROUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0550-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0550-3) </PackageDescription>
<NDC11Code>37662-0550-03</NDC11Code>
<ProductNDC>37662-0550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Conium Maculatum</ProprietaryName>
<NonProprietaryName>Conium Maculatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220614</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CONIUM MACULATUM FLOWERING TOP</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>38779-0550-3</NDCCode>
<PackageDescription>5000 g in 1 PAIL (38779-0550-3)</PackageDescription>
<NDC11Code>38779-0550-03</NDC11Code>
<ProductNDC>38779-0550</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sulfadiazine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120416</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>SULFADIAZINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63190-0550-3</NDCCode>
<PackageDescription>30 kg in 1 DRUM (63190-0550-3)</PackageDescription>
<NDC11Code>63190-0550-03</NDC11Code>
<ProductNDC>63190-0550</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gestodene</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20141231</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Industriale Chimica s.r.l.</LabelerName>
<SubstanceName>GESTODENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-12-17</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69968-0550-3</NDCCode>
<PackageDescription>3700 mL in 1 BOTTLE (69968-0550-3) </PackageDescription>
<NDC11Code>69968-0550-03</NDC11Code>
<ProductNDC>69968-0550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Listerine Cool Mint Antiseptic</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, And Thymol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent and reduce: 1 Plaque, 2 Gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0550-3</NDCCode>
<PackageDescription>100 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0550-3) </PackageDescription>
<NDC11Code>71335-0550-03</NDC11Code>
<ProductNDC>71335-0550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dok</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0069-0550-38</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0069-0550-38) </PackageDescription>
<NDC11Code>00069-0550-38</NDC11Code>
<ProductNDC>0069-0550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sutent</ProprietaryName>
<NonProprietaryName>Sunitinib Malate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021938</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>SUNITINIB MALATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUTENT is a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
<Description>Sunitinib is a kinase inhibitor present in SUTENT capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 ∙ C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and povidone (K-25). The orange gelatin capsule shells contain titanium dioxide and red iron oxide; the caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide; and the yellow gelatin capsule shells contain titanium dioxide and yellow iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide and the black printing ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0597-0555-80</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0597-0555-80) / 1 KIT in 1 KIT * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET * 1 SYRINGE in 1 TRAY (0597-0550-06) / .4 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00597-0555-80</NDC11Code>
<ProductNDC>0597-0555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab-adbm</ProprietaryName>
<NonProprietaryName>Adalimumab-adbm</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761058</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>10122-550-28</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>10122-0550-28</NDC11Code>
<ProductNDC>10122-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycapssa</ProprietaryName>
<NonProprietaryName>Octreotide</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208232</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>OCTREOTIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.</IndicationAndUsage>
<Description>MYCAPSSA delayed release capsules contain octreotide acetate, a somatostatin analog. Octreotide is known chemically as L-cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 (free peptide, C49H66N10O10S2) and its amino acid sequence is. MYCAPSSA (octreotide) delayed-release capsules are enteric-coated capsules for oral use. Each capsule contains 20 mg of octreotide (provided as octreotide acetate). Octreotide is present as a salt with 1.4 to 2.5 molar equivalents of acetate. The capsules contain the following inactive ingredients: polyvinylpyrrolidone (PVP-12), sodium caprylate, magnesium chloride, polysorbate 80, glyceryl monocaprylate, glyceryl tricaprylate, gelatin, gelatin capsules, and Acryl-EZE® (methacrylate). The capsule is printed with "OT 20" in Opacode® black ink.</Description>
</NDC>
<NDC>
<NDCCode>13668-550-94</NDCCode>
<PackageDescription>30 GRANULE, DELAYED RELEASE in 1 CARTON (13668-550-94) </PackageDescription>
<NDC11Code>13668-0550-94</NDC11Code>
<ProductNDC>13668-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<ProprietaryNameSuffix>For Delayed-release Oral Suspension</ProprietaryNameSuffix>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>GRANULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212651</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium for delayed-release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed-release oral suspension is indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg with molecular weight of 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. The stability of esomeprazole magnesium USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium for delayed-release oral suspension is supplied in packets. Each packet of Esomeprazole magnesium for delayed-release oral suspension contains esomeprazole magnesium USP equivalent to esomeprazole 2.5 mg, 5 mg, 20 mg, or 40 mg, in the form of enteric-coated pellets. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of enteric-coated pellets, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.588 mg esomeprazole magnesium USP), 2 5 mg esomeprazole (equivalent to 5.176 mg esomeprazole magnesium USP), 3 20 mg esomeprazole (equivalent to 20.706 mg esomeprazole magnesium USP), 4 40 mg esomeprazole (equivalent to 41.411 mg esomeprazole magnesium USP).</Description>
</NDC>
<NDC>
<NDCCode>16714-550-01</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16714-550-01) </PackageDescription>
<NDC11Code>16714-0550-01</NDC11Code>
<ProductNDC>16714-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208308</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 1 month of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>16729-550-10</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16729-550-10) </PackageDescription>
<NDC11Code>16729-0550-10</NDC11Code>
<ProductNDC>16729-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209069</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
<StrengthNumber>8; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine and Naloxone Sublingual Tablets, USP are uncoated white to off-white, round biconvex tablets, debossed with an alpha-numeric imprint identifying the product and strength on one side, and plain on the other. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). They are intended for sublingual administration and are available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains citric acid anhydrous, crospovidone, lactose monohydrate, magnesium stearate, mannitol, corn syrup solids, modified food starch, natural lemon flavor, pregelatinized starch (maize), povidone, sodium citrate dihydrate, and sucralose. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4, 5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4HCl2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>17139-550-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (17139-550-30) / 5 g in 1 PACKET</PackageDescription>
<NDC11Code>17139-0550-30</NDC11Code>
<ProductNDC>17139-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Androgel</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20230217</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021015</ApplicationNumber>
<LabelerName>ASCEND Therapeutics U.S., LLC</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AndroGel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .</IndicationAndUsage>
<Description>AndroGel 1% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1% is available in a metered-dose pump or unit dose packets. The active pharmacologic ingredient in AndroGel 1% is testosterone, an androgen. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.</Description>
</NDC>
<NDC>
<NDCCode>23155-550-31</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (23155-550-31) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>23155-0550-31</NDC11Code>
<ProductNDC>23155-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20151109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090648</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1), 2 postoperative nausea and/or vomiting. (1.2).</IndicationAndUsage>
<Description>The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2 mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Each 1 mL of aqueous solution in the 20 mL multi-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0.</Description>
</NDC>
<NDC>
<NDCCode>24338-550-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (24338-550-01) </PackageDescription>
<NDC11Code>24338-0550-01</NDC11Code>
<ProductNDC>24338-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suflave</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215344</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative and is provided in two bottles and two flavor enhancing packets for oral solution. The active ingredients contained in SUFLAVE are provided in Table 3. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride, plus the following excipients: advantame, lemon-lime flavor, and neotame. Each flavor enhancing packet contains anhydrous citric acid, colloidal silicon dioxide, malic acid, and sucralose. Each dose of reconstituted oral solution is one liter of slightly hazy to hazy liquid that contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride and the following excipients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>28595-550-12</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (28595-550-12) / 200 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>28595-0550-12</NDC11Code>
<ProductNDC>28595-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrolingual</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018705</ApplicationNumber>
<LabelerName>Allegis Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C 3H 5N 3O 9). The compound has a molecular weight of 227.09. The chemical structure is:. CH 2–ONO 2. |. CH–ONO 2. |. CH 2–ONO 2. Nitrolingual Pumpspray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil, sodium lactate, lactic acid.</Description>
</NDC>
<NDC>
<NDCCode>28595-550-49</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (28595-550-49) / 60 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>28595-0550-49</NDC11Code>
<ProductNDC>28595-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrolingual</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018705</ApplicationNumber>
<LabelerName>Allegis Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C 3H 5N 3O 9). The compound has a molecular weight of 227.09. The chemical structure is:. CH 2–ONO 2. |. CH–ONO 2. |. CH 2–ONO 2. Nitrolingual Pumpspray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil, sodium lactate, lactic acid.</Description>
</NDC>
<NDC>
<NDCCode>31722-550-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-550-30) </PackageDescription>
<NDC11Code>31722-0550-30</NDC11Code>
<ProductNDC>31722-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217443</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate capsules are an extended-release capsule. Topiramate extended-release capsules, USP contain the following inactive ingredients. hydroxy propyl methyl cellulose, sugar spheres, starch (maze), sucrose, talc, ethylcellulose, ammonium hydroxide, medium chain triglycerides, oleic acid, polyvinyl alcohol, lecithin, xanthan gum, polyethylene glycol, gelatin, titanium dioxide and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows:25 mg: FD&C yellow 6, D&C yellow 10, FD&C blue 1 and iron oxide yellow50 mg: FD&C yellow 6, FD&C blue 1 and iron oxide yellow100 mg: FD&C yellow 6 and FD&C blue 1200 mg: FD&C blue 1 and FD&C yellow 6. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>33261-550-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE, PLASTIC (33261-550-06)</PackageDescription>
<NDC11Code>33261-0550-06</NDC11Code>
<ProductNDC>33261-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040268</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33261-550-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-550-30)</PackageDescription>
<NDC11Code>33261-0550-30</NDC11Code>
<ProductNDC>33261-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040268</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33342-550-09</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (33342-550-09) </PackageDescription>
<NDC11Code>33342-0550-09</NDC11Code>
<ProductNDC>33342-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nintedanib Esylate</ProprietaryName>
<NonProprietaryName>Nintedanib Esylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219926</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>NINTEDANIB ESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nintedanib capsules are kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) (1.1) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (1.2).</IndicationAndUsage>
<Description>Nintedanib capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-,methyl ester, (3Z)-, ethanesulfonate (1:1). Its structural fomula is. Nintedanib esylate is a Greenish yellow to bright yellow powder with an empirical formula of C33H39N5O7S and a molecular weight of 649.76 g/mol. Nintedanib capsules for oral administration are available in 2 dose strengths containing 100 mg or 150 mg of nintedanib (equivalent to 120.40 mg or 180.60 mg nintedanib esylate respectively). The inactive ingredients of nintedanib capsules are the following: Fill Material: polyethylene glycol, caprylocaproyl polyoxyl-8 glycerides and triglycerides. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide, Imprinting Ink: shellac glaze, ferrosoferric oxide/black iron oxide, propylene glycol, ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>37012-550-30</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (37012-550-30) > 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37012-0550-30</NDC11Code>
<ProductNDC>37012-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Shopko Stores Operating Co., LLC.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for relief of: 1 bloating, 2 pressure, 3 fullness, 4 stuffed feeling commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42195-550-14</NDCCode>
<PackageDescription>14 CONTAINER in 1 CARTON (42195-550-14) / .25 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>42195-0550-14</NDC11Code>
<ProductNDC>42195-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin Otic</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20120827</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021918</ApplicationNumber>
<LabelerName>Xspire Pharma, Llc</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/.25mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin Otic Solution is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosaor Staphylococcus aureus.</IndicationAndUsage>
<Description>Ciprofloxacin Otic Solution 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin Otic Solution is a sterile, preservative-free solution for otic use. Each single use container of Ciprofloxacin Otic Solution delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH. Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17H 18FN 3O 3HClH 2O, and molecular weight is 385.82. The chemical structure of ciprofloxacin hydrochloride is.</Description>
</NDC>
<NDC>
<NDCCode>42346-550-85</NDCCode>
<PackageDescription>85 g in 1 TUBE (42346-550-85) </PackageDescription>
<NDC11Code>42346-0550-85</NDC11Code>
<ProductNDC>42346-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothing Nerve Therapy</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Wise Consumer Products</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42346-550-86</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42346-550-86) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>42346-0550-86</NDC11Code>
<ProductNDC>42346-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothing Nerve Therapy</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Wise Consumer Products</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42346-550-87</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (42346-550-87) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>42346-0550-87</NDC11Code>
<ProductNDC>42346-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothing Nerve Therapy</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Wise Consumer Products</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-550-32</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42829-550-32) / 7 g in 1 TUBE</PackageDescription>
<NDC11Code>42829-0550-32</NDC11Code>
<ProductNDC>42829-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zilactin-b</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves pain caused by: 1 canker sores, 2 minor mouth sores and gum irritations, 3 denture and brace pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43386-550-04</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (43386-550-04) </PackageDescription>
<NDC11Code>43386-0550-04</NDC11Code>
<ProductNDC>43386-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tinidazole</ProprietaryName>
<NonProprietaryName>Tinidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202044</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>TINIDAZOLE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: 1 Trichomoniasis (1.1), 2 Giardiasis: in patients age 3 and older (1.2), 3 Amebiasis: in patients age 3 and older (1.3), 4 Bacterial Vaginosis: in adult women (1.4, 8.1).</IndicationAndUsage>
<Description>Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure. Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include pregelatinized starch NF, croscarmellose sodium NF, magnesium stearate NF, microcrystalline cellulose NF, polyvinyl alcohol-part hydrolyzed USP, titanium dioxide USP, polyethylene glycol 3000 NF, talc USP, and FD&C red # 40 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>43598-550-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-550-01) </PackageDescription>
<NDC11Code>43598-0550-01</NDC11Code>
<ProductNDC>43598-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206382</ApplicationNumber>
<LabelerName>Dr. Reddy�s Laboratories Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older. : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. ( 1.1) .</IndicationAndUsage>
<Description>Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.1. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in anhydrous ethanol, practically insoluble in dilute hydrochloric acid and in water. The structural formula is:. Lamotrigine Orally Disintegrating Tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: amino methacrylate copolymer, aspartame, colloidal silicon dioxide, crospovidone, kollidon SR, magnesium stearate, mannitol, sucralose and artificial cherry flavor containing dextrose, corn starch, and tricalcium phosphate.</Description>
</NDC>
</NDCList>