{
"NDC": [
{
"NDCCode": "42806-569-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42806-569-60) ",
"NDC11Code": "42806-0569-60",
"ProductNDC": "42806-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nintedanib",
"NonProprietaryName": "Nintedanib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218472",
"LabelerName": "EPIC PHARMA LLC",
"SubstanceName": "NINTEDANIB ESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260709",
"SamplePackage": "N",
"IndicationAndUsage": "Nintedanib capsules are a kinase inhibitor indicated in adults for: 1 Treatment of idiopathic pulmonary fibrosis (IPF). ( 1.1) , 2 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 name 1H-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 formula is. Nintedanib esylate is a bright yellow powder with an empirical formula of C 31H 33N 5O 4·C 2H 6O 3S 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 ethanesulfonate, respectively). The inactive ingredients of nintedanib capsules are the following: Fill Material: medium-chain triglycerides, hard fat and lecithin. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide, purified water. Imprinting black ink: ammonia hydroxide, black iron oxide non-IRR, propylene glycol and shellac glaze (modified) in SD-45."
},
{
"NDCCode": "13668-569-05",
"PackageDescription": "60 g in 1 TUBE (13668-569-05) ",
"NDC11Code": "13668-0569-05",
"ProductNDC": "13668-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211836",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241215",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream USP is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate cream, USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß, 16ß)-21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1- oxopropoxy)-pregna-1, 4- diene-3, 20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base of cetyl alcohol, citric acid anhydrous, glycol stearate, lanolin oil, methylparaben, polyoxyl 8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum (white soft paraffin). Sodium hydroxide may be used to adjust pH."
},
{
"NDCCode": "16252-569-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE, PLASTIC (16252-569-60)",
"NDC11Code": "16252-0569-60",
"ProductNDC": "16252-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077868",
"LabelerName": "Cobalt Laboratories",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "21695-569-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (21695-569-60)",
"NDC11Code": "21695-0569-60",
"ProductNDC": "21695-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorzoxazone",
"NonProprietaryName": "Chlorzoxazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089895",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CHLORZOXAZONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.",
"Description": "Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is. C7H4CINO2 MW 169.57. Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone tablets contain the inactive ingredients Docusate Sodium, Lactose (hydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sodium Benzoate, and Sodium Starch Glycolate."
},
{
"NDCCode": "42549-569-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42549-569-60)",
"NDC11Code": "42549-0569-60",
"ProductNDC": "42549-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077184",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablet is indicated for the short-term (five days or less) management of acute pain.",
"Description": "Tramadol hydrochloride and acetaminophen tablet for oral administration (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) combines two analgesics, tramadol and acetaminophen. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclo-hexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H13NO2.HC1. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular formula of acetaminophen is C8H9NO2. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, corn starch, magnesium stearate, opadry yellow and povidone. In addition, opadry yellow contains: hydroxypropyl methyl cellulose, titanium dioxide, macrogol, talc, and iron oxide yellow."
},
{
"NDCCode": "43353-569-53",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-569-53)",
"NDC11Code": "43353-0569-53",
"ProductNDC": "43353-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205119",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets, USP are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2."
},
{
"NDCCode": "43744-569-60",
"PackageDescription": "750 g in 1 DRUM (43744-569-60)",
"NDC11Code": "43744-0569-60",
"ProductNDC": "43744-569",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Medetomidine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110920",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "47781-569-26",
"PackageDescription": "1 TUBE in 1 CARTON (47781-569-26) / 60 g in 1 TUBE",
"NDC11Code": "47781-0569-26",
"ProductNDC": "47781-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171002",
"EndMarketingDate": "20241101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016909",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171002",
"EndMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Ointment, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Ointment contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, white petrolatum, propylene carbonate, propylene glycol and white wax. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "53097-569-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (53097-569-60) > 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "53097-0569-60",
"ProductNDC": "53097-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marinol",
"NonProprietaryName": "Dronabinol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018651",
"LabelerName": "ThePharmaNetwork, LLC",
"SubstanceName": "DRONABINOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cannabinoid [EPC], Cannabinoids [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2020-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170510",
"SamplePackage": "N",
"IndicationAndUsage": "MARINOL is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.",
"Description": "Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C21H30O2 (molecular weight = 314.46) Dronabinol, the active ingredient in MARINOL (dronabinol capsules, USP), is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Each MARINOL capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide."
},
{
"NDCCode": "55289-569-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (55289-569-60) ",
"NDC11Code": "55289-0569-60",
"ProductNDC": "55289-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "55700-569-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55700-569-60) ",
"NDC11Code": "55700-0569-60",
"ProductNDC": "55700-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077802",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20171221",
"SamplePackage": "N"
},
{
"NDCCode": "57691-569-60",
"PackageDescription": "60 mL in 1 BOTTLE (57691-569-60)",
"NDC11Code": "57691-0569-60",
"ProductNDC": "57691-569",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pink Grapefruit",
"ProprietaryNameSuffix": "Antibacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100915",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "The Body Shop Wake Forest",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".734",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hand washing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "61355-569-60",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CANISTER (61355-569-60) > 60 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "61355-0569-60",
"ProductNDC": "61355-569",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Toppik Womens Hair Regrowth Treatment",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "Spencer Forrest, Inc.",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "62756-569-86",
"PackageDescription": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-569-86) ",
"NDC11Code": "62756-0569-86",
"ProductNDC": "62756-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209782",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate."
},
{
"NDCCode": "63187-569-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (63187-569-60) ",
"NDC11Code": "63187-0569-60",
"ProductNDC": "63187-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N",
"IndicationAndUsage": "Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.",
"Description": "Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown."
},
{
"NDCCode": "67209-569-26",
"PackageDescription": "12 CARTON in 1 BOX (67209-569-26) > 1 TUBE in 1 CARTON > 60 g in 1 TUBE",
"NDC11Code": "67209-0569-26",
"ProductNDC": "67209-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171002",
"MarketingCategoryName": "APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"ApplicationNumber": "NDA016909",
"LabelerName": "WellSpring Pharma Services Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "67544-569-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (67544-569-53) ",
"NDC11Code": "67544-0569-53",
"ProductNDC": "67544-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071655",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).",
"Description": "Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears below. C22H31NO3HCl M.W. 393.9. Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake. Oxybutynin Chloride Tablets USP are for oral administration. Meets USP Dissolution Test 2. Therapeutic Category: Antispasmodic, anticholinergic."
},
{
"NDCCode": "67544-569-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (67544-569-60) ",
"NDC11Code": "67544-0569-60",
"ProductNDC": "67544-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071655",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).",
"Description": "Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears below. C22H31NO3HCl M.W. 393.9. Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake. Oxybutynin Chloride Tablets USP are for oral administration. Meets USP Dissolution Test 2. Therapeutic Category: Antispasmodic, anticholinergic."
},
{
"NDCCode": "67877-569-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (67877-569-60) > 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "67877-0569-60",
"ProductNDC": "67877-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dronabinol",
"NonProprietaryName": "Dronabinol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170510",
"EndMarketingDate": "20210430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018651",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DRONABINOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cannabinoid [EPC],Cannabinoids [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170510",
"EndMarketingDatePackage": "20210430",
"SamplePackage": "N"
},
{
"NDCCode": "68180-569-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-569-07) ",
"NDC11Code": "68180-0569-07",
"ProductNDC": "68180-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200751",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "N"
},
{
"NDCCode": "71205-569-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-569-60) ",
"NDC11Code": "71205-0569-60",
"ProductNDC": "71205-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200503",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210526",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets USP contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Tramadol hydrochloride extended-release tablets USP meet USP Dissolution Test 3."
},
{
"NDCCode": "76420-569-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (76420-569-60) ",
"NDC11Code": "76420-0569-60",
"ProductNDC": "76420-569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 90",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110203",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "57; 13.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230516",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: NP Thyroid® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "NP Thyroid® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)."
},
{
"NDCCode": "84828-569-00",
"PackageDescription": "1 KIT in 1 KIT (84828-569-00) * 1 BOTTLE, DROPPER in 1 KIT (84828-539-00) / 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "84828-0569-00",
"ProductNDC": "84828-569",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "KIT",
"StartMarketingDate": "20240911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "Invest Strong, LLC",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240911",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "42806-086-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42806-086-60) ",
"NDC11Code": "42806-0086-60",
"ProductNDC": "42806-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208972",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2019-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190417",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42806-178-60",
"PackageDescription": "60 g in 1 BOTTLE (42806-178-60) ",
"NDC11Code": "42806-0178-60",
"ProductNDC": "42806-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin Topical Powder",
"NonProprietaryName": "Nystatin Topical Powder",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210532",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "U/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2018-05-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180502",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.09. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc."
},
{
"NDCCode": "42806-185-60",
"PackageDescription": "60 g in 1 BOTTLE (42806-185-60) ",
"NDC11Code": "42806-0185-60",
"ProductNDC": "42806-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin Topical Powder",
"NonProprietaryName": "Nystatin Topical Powder",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210532",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "U/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230414",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.09. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin."
},
{
"NDCCode": "42806-186-60",
"PackageDescription": "60 g in 1 BOTTLE (42806-186-60) ",
"NDC11Code": "42806-0186-60",
"ProductNDC": "42806-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Klayesta",
"NonProprietaryName": "Nystatin Topical Powder",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210532",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "U/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230414",
"SamplePackage": "N",
"IndicationAndUsage": "KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.09. Structural formula. KLAYESTA is for dermatologic use. KLAYESTA contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin."
},
{
"NDCCode": "42806-260-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42806-260-60) ",
"NDC11Code": "42806-0260-60",
"ProductNDC": "42806-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078012",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170323",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "42806-266-95",
"PackageDescription": "60 POUCH in 1 CARTON (42806-266-95) / 9 g in 1 POUCH (42806-266-98) ",
"NDC11Code": "42806-0266-95",
"ProductNDC": "42806-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cholestyramine",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074557",
"LabelerName": "EPIC PHARMA, LLC",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/9g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "1) Cholestyramine for Oral Suspension, USP powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for Oral Suspension, USP powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. *Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). : 1 †Other risk factors for coronary heart disease (CHD) include: age (males 45 years; females: 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is 60 mg/dL (1.6 mmol/L).",
"Description": "Cholestyramine for Oral Suspension, USP powder, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. Cholestyramine resin is not absorbed from the digestive tract. Each Nine grams of Cholestyramine for Oral Suspension, USP powder contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Representation of structure of main polymeric groups. Inactive ingredients: citric acid anhydrous, fructose, mono ammonium glycyrrhizinate, pectin, propylene glycol alginate, sorbitol, sucrose, xanthan gum, natural and artificial orange flavor, D&C yellow No. 10 aluminum lake, FD&C yellow No. 6 aluminum lake."
},
{
"NDCCode": "42806-270-95",
"PackageDescription": "60 POUCH in 1 CARTON (42806-270-95) / 5.7 g in 1 POUCH (42806-270-98) ",
"NDC11Code": "42806-0270-95",
"ProductNDC": "42806-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cholestyramine Light",
"NonProprietaryName": "Cholestyramine Light",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074558",
"LabelerName": "EPIC PHARMA, LLC",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/5.7g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "1) Cholestyramine for Oral Suspension, USP Light powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for Oral Suspension, USP Light powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. *Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). : 1 †Other risk factors for coronary heart disease (CHD) include: age (males 45 years; females: 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is 60 mg/dL (1.6 mmol/L).",
"Description": "Cholestyramine for Oral Suspension, USP Light powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. Cholestyramine resin is not absorbed from the digestive tract. Each 5.7 grams of Cholestyramine for Oral Suspension, USP Light powder contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Representation of structure of main polymeric groups. Inactive Ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, fructose, mannitol, mono ammonium glycyrrhizinate, pectin, propylene glycol alginate, sorbitol, xanthan gum, natural and artificial orange flavor, D&C yellow No. 10 aluminum lake and FD&C yellow No. 6 aluminum lake."
}
]
}
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<NDC>
<NDCCode>42806-569-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42806-569-60) </PackageDescription>
<NDC11Code>42806-0569-60</NDC11Code>
<ProductNDC>42806-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nintedanib</ProprietaryName>
<NonProprietaryName>Nintedanib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218472</ApplicationNumber>
<LabelerName>EPIC PHARMA LLC</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>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nintedanib capsules are a kinase inhibitor indicated in adults for: 1 Treatment of idiopathic pulmonary fibrosis (IPF). ( 1.1) , 2 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 name 1H-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 formula is. Nintedanib esylate is a bright yellow powder with an empirical formula of C 31H 33N 5O 4·C 2H 6O 3S 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 ethanesulfonate, respectively). The inactive ingredients of nintedanib capsules are the following: Fill Material: medium-chain triglycerides, hard fat and lecithin. Capsule Shell: gelatin, glycerin, titanium dioxide, red ferric oxide, yellow ferric oxide, purified water. Imprinting black ink: ammonia hydroxide, black iron oxide non-IRR, propylene glycol and shellac glaze (modified) in SD-45.</Description>
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<NDC>
<NDCCode>13668-569-05</NDCCode>
<PackageDescription>60 g in 1 TUBE (13668-569-05) </PackageDescription>
<NDC11Code>13668-0569-05</NDC11Code>
<ProductNDC>13668-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211836</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream USP is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate cream, USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß, 16ß)-21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1- oxopropoxy)-pregna-1, 4- diene-3, 20-dione, and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base of cetyl alcohol, citric acid anhydrous, glycol stearate, lanolin oil, methylparaben, polyoxyl 8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum (white soft paraffin). Sodium hydroxide may be used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>16252-569-60</NDCCode>
<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE, PLASTIC (16252-569-60)</PackageDescription>
<NDC11Code>16252-0569-60</NDC11Code>
<ProductNDC>16252-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077868</ApplicationNumber>
<LabelerName>Cobalt Laboratories</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>21695-569-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (21695-569-60)</PackageDescription>
<NDC11Code>21695-0569-60</NDC11Code>
<ProductNDC>21695-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorzoxazone</ProprietaryName>
<NonProprietaryName>Chlorzoxazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089895</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CHLORZOXAZONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is. C7H4CINO2 MW 169.57. Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone tablets contain the inactive ingredients Docusate Sodium, Lactose (hydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sodium Benzoate, and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42549-569-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42549-569-60)</PackageDescription>
<NDC11Code>42549-0569-60</NDC11Code>
<ProductNDC>42549-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077184</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablet is indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablet for oral administration (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) combines two analgesics, tramadol and acetaminophen. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclo-hexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H13NO2.HC1. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular formula of acetaminophen is C8H9NO2. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, corn starch, magnesium stearate, opadry yellow and povidone. In addition, opadry yellow contains: hydroxypropyl methyl cellulose, titanium dioxide, macrogol, talc, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>43353-569-53</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-569-53)</PackageDescription>
<NDC11Code>43353-0569-53</NDC11Code>
<ProductNDC>43353-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205119</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets, USP are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>43744-569-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-569-60)</PackageDescription>
<NDC11Code>43744-0569-60</NDC11Code>
<ProductNDC>43744-569</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Medetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110920</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-569-26</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (47781-569-26) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>47781-0569-26</NDC11Code>
<ProductNDC>47781-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<EndMarketingDate>20241101</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016909</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171002</StartMarketingDatePackage>
<EndMarketingDatePackage>20241101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Ointment, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Ointment contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, white petrolatum, propylene carbonate, propylene glycol and white wax. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>53097-569-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (53097-569-60) > 60 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>53097-0569-60</NDC11Code>
<ProductNDC>53097-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marinol</ProprietaryName>
<NonProprietaryName>Dronabinol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018651</ApplicationNumber>
<LabelerName>ThePharmaNetwork, LLC</LabelerName>
<SubstanceName>DRONABINOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cannabinoid [EPC], Cannabinoids [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2020-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARINOL is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.</IndicationAndUsage>
<Description>Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C21H30O2 (molecular weight = 314.46) Dronabinol, the active ingredient in MARINOL (dronabinol capsules, USP), is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Each MARINOL capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-569-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (55289-569-60) </PackageDescription>
<NDC11Code>55289-0569-60</NDC11Code>
<ProductNDC>55289-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>55700-569-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55700-569-60) </PackageDescription>
<NDC11Code>55700-0569-60</NDC11Code>
<ProductNDC>55700-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077802</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57691-569-60</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (57691-569-60)</PackageDescription>
<NDC11Code>57691-0569-60</NDC11Code>
<ProductNDC>57691-569</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pink Grapefruit</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial Hand Sanitizer</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>The Body Shop Wake Forest</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.734</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hand washing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61355-569-60</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CANISTER (61355-569-60) > 60 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>61355-0569-60</NDC11Code>
<ProductNDC>61355-569</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Toppik Womens Hair Regrowth Treatment</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>Spencer Forrest, Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62756-569-86</NDCCode>
<PackageDescription>60 TABLET, FOR SUSPENSION in 1 BOTTLE (62756-569-86) </PackageDescription>
<NDC11Code>62756-0569-86</NDC11Code>
<ProductNDC>62756-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209782</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>63187-569-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (63187-569-60) </PackageDescription>
<NDC11Code>63187-0569-60</NDC11Code>
<ProductNDC>63187-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown.</Description>
</NDC>
<NDC>
<NDCCode>67209-569-26</NDCCode>
<PackageDescription>12 CARTON in 1 BOX (67209-569-26) > 1 TUBE in 1 CARTON > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>67209-0569-26</NDC11Code>
<ProductNDC>67209-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<MarketingCategoryName>APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<ApplicationNumber>NDA016909</ApplicationNumber>
<LabelerName>WellSpring Pharma Services Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>67544-569-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (67544-569-53) </PackageDescription>
<NDC11Code>67544-0569-53</NDC11Code>
<ProductNDC>67544-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071655</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
<Description>Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears below. C22H31NO3HCl M.W. 393.9. Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake. Oxybutynin Chloride Tablets USP are for oral administration. Meets USP Dissolution Test 2. Therapeutic Category: Antispasmodic, anticholinergic.</Description>
</NDC>
<NDC>
<NDCCode>67544-569-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67544-569-60) </PackageDescription>
<NDC11Code>67544-0569-60</NDC11Code>
<ProductNDC>67544-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071655</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
<Description>Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears below. C22H31NO3HCl M.W. 393.9. Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake. Oxybutynin Chloride Tablets USP are for oral administration. Meets USP Dissolution Test 2. Therapeutic Category: Antispasmodic, anticholinergic.</Description>
</NDC>
<NDC>
<NDCCode>67877-569-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (67877-569-60) > 60 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>67877-0569-60</NDC11Code>
<ProductNDC>67877-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dronabinol</ProprietaryName>
<NonProprietaryName>Dronabinol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170510</StartMarketingDate>
<EndMarketingDate>20210430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018651</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DRONABINOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cannabinoid [EPC],Cannabinoids [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170510</StartMarketingDatePackage>
<EndMarketingDatePackage>20210430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-569-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-569-07) </PackageDescription>
<NDC11Code>68180-0569-07</NDC11Code>
<ProductNDC>68180-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200751</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-569-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-569-60) </PackageDescription>
<NDC11Code>71205-0569-60</NDC11Code>
<ProductNDC>71205-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200503</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets USP contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Tramadol hydrochloride extended-release tablets USP meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>76420-569-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (76420-569-60) </PackageDescription>
<NDC11Code>76420-0569-60</NDC11Code>
<ProductNDC>76420-569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 90</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>57; 13.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: NP Thyroid® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>NP Thyroid® (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
</NDC>
<NDC>
<NDCCode>84828-569-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (84828-569-00) * 1 BOTTLE, DROPPER in 1 KIT (84828-539-00) / 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>84828-0569-00</NDC11Code>
<ProductNDC>84828-569</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>Invest Strong, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42806-086-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42806-086-60) </PackageDescription>
<NDC11Code>42806-0086-60</NDC11Code>
<ProductNDC>42806-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208972</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42806-178-60</NDCCode>
<PackageDescription>60 g in 1 BOTTLE (42806-178-60) </PackageDescription>
<NDC11Code>42806-0178-60</NDC11Code>
<ProductNDC>42806-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin Topical Powder</ProprietaryName>
<NonProprietaryName>Nystatin Topical Powder</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210532</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>U/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-05-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.09. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
</NDC>
<NDC>
<NDCCode>42806-185-60</NDCCode>
<PackageDescription>60 g in 1 BOTTLE (42806-185-60) </PackageDescription>
<NDC11Code>42806-0185-60</NDC11Code>
<ProductNDC>42806-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin Topical Powder</ProprietaryName>
<NonProprietaryName>Nystatin Topical Powder</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210532</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>U/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.09. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin.</Description>
</NDC>
<NDC>
<NDCCode>42806-186-60</NDCCode>
<PackageDescription>60 g in 1 BOTTLE (42806-186-60) </PackageDescription>
<NDC11Code>42806-0186-60</NDC11Code>
<ProductNDC>42806-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Klayesta</ProprietaryName>
<NonProprietaryName>Nystatin Topical Powder</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210532</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>U/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.09. Structural formula. KLAYESTA is for dermatologic use. KLAYESTA contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin.</Description>
</NDC>
<NDC>
<NDCCode>42806-260-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42806-260-60) </PackageDescription>
<NDC11Code>42806-0260-60</NDC11Code>
<ProductNDC>42806-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078012</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL-and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: calcium stearate NF, carnauba wax NF, colloidal silicon dioxide NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350 NF, polyvinyl alcohol USP, pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and titanium dioxide USP. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>42806-266-95</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (42806-266-95) / 9 g in 1 POUCH (42806-266-98) </PackageDescription>
<NDC11Code>42806-0266-95</NDC11Code>
<ProductNDC>42806-266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cholestyramine</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074557</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/9g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Cholestyramine for Oral Suspension, USP powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for Oral Suspension, USP powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. *Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). : 1 †Other risk factors for coronary heart disease (CHD) include: age (males 45 years; females: 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is 60 mg/dL (1.6 mmol/L).</IndicationAndUsage>
<Description>Cholestyramine for Oral Suspension, USP powder, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. Cholestyramine resin is not absorbed from the digestive tract. Each Nine grams of Cholestyramine for Oral Suspension, USP powder contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Representation of structure of main polymeric groups. Inactive ingredients: citric acid anhydrous, fructose, mono ammonium glycyrrhizinate, pectin, propylene glycol alginate, sorbitol, sucrose, xanthan gum, natural and artificial orange flavor, D&C yellow No. 10 aluminum lake, FD&C yellow No. 6 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>42806-270-95</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (42806-270-95) / 5.7 g in 1 POUCH (42806-270-98) </PackageDescription>
<NDC11Code>42806-0270-95</NDC11Code>
<ProductNDC>42806-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cholestyramine Light</ProprietaryName>
<NonProprietaryName>Cholestyramine Light</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074558</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/5.7g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Cholestyramine for Oral Suspension, USP Light powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for Oral Suspension, USP Light powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. *Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). : 1 †Other risk factors for coronary heart disease (CHD) include: age (males 45 years; females: 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is 60 mg/dL (1.6 mmol/L).</IndicationAndUsage>
<Description>Cholestyramine for Oral Suspension, USP Light powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. Cholestyramine resin is not absorbed from the digestive tract. Each 5.7 grams of Cholestyramine for Oral Suspension, USP Light powder contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Representation of structure of main polymeric groups. Inactive Ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, fructose, mannitol, mono ammonium glycyrrhizinate, pectin, propylene glycol alginate, sorbitol, xanthan gum, natural and artificial orange flavor, D&C yellow No. 10 aluminum lake and FD&C yellow No. 6 aluminum lake.</Description>
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