{
"NDC": [
{
"NDCCode": "42291-680-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-680-90)",
"NDC11Code": "42291-0680-90",
"ProductNDC": "42291-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091450",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "21695-680-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (21695-680-90)",
"NDC11Code": "21695-0680-90",
"ProductNDC": "21695-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040901",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6."
},
{
"NDCCode": "33261-680-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-680-90)",
"NDC11Code": "33261-0680-90",
"ProductNDC": "33261-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20081125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077284",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Major Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Seasonal Affective Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder. The efficacy of bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see CLINICAL TRIALS). Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.",
"Description": "Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150-mg and 300-mg, round white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: dehydrated alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, hydrogenated vegetable oil and ethyl alcohol. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP drug release testing is pending."
},
{
"NDCCode": "35356-680-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (35356-680-90)",
"NDC11Code": "35356-0680-90",
"ProductNDC": "35356-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19920701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073554",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "41250-680-75",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-680-75) / 90 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "41250-0680-75",
"ProductNDC": "41250-680",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074661",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:minor pain of arthritismuscular achesbackachemenstrual crampsheadachetoothachethe common cold. temporarily reduces fever."
},
{
"NDCCode": "51655-680-26",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-680-26) ",
"NDC11Code": "51655-0680-26",
"ProductNDC": "51655-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220504",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets."
},
{
"NDCCode": "58980-680-90",
"PackageDescription": "1 TUBE in 1 BOX (58980-680-90) > 255 g in 1 TUBE",
"NDC11Code": "58980-0680-90",
"ProductNDC": "58980-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remeven",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Stratus Pharmaceuticals, Inc",
"SubstanceName": "UREA",
"StrengthNumber": "71",
"StrengthUnit": "g/142g",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "62135-680-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-680-90) ",
"NDC11Code": "62135-0680-90",
"ProductNDC": "62135-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "63187-680-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-680-90) ",
"NDC11Code": "63187-0680-90",
"ProductNDC": "63187-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072192",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)].",
"Description": "Trazodone hydrochloride is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water. Chemical Name: 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride. Structural Formula. Molecular Formula: C19H22ClN5OHCl. Molecular Weight: 408.32. Each tablet, for oral administration, contains 50 mg or 100 mg of trazodone hydrochloride, USP. In addition, each tablet contains hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "65162-680-90",
"PackageDescription": "473 mL in 1 BOTTLE (65162-680-90) ",
"NDC11Code": "65162-0680-90",
"ProductNDC": "65162-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090575",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "6.25; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110304",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide USP, 15 mg; promethazine hydrochloride USP, 6.25 mg. Alcohol 7%. Inactive Ingredients: ascorbic acid, citric acid, edetate disodium, FD&C Yellow #6, glycerin, methylparaben, natural & artificial flavors, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Dextromethorphan hydrobromide, USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α,13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide, USP occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH20, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as \"10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride\". Promethazine hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S HCl, and the following structural formula."
},
{
"NDCCode": "71610-680-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-680-60) ",
"NDC11Code": "71610-0680-60",
"ProductNDC": "71610-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074497",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221209",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide Tablets USP are an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[ p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide Tablets USP for oral use are available in 5 and 10 mg strengths. Each tablet contains the following inactive ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinized corn starch; silicon dioxide; stearic acid."
},
{
"NDCCode": "72189-680-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (72189-680-90) ",
"NDC11Code": "72189-0680-90",
"ProductNDC": "72189-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hcl",
"NonProprietaryName": "Cyclobenzaprine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077563",
"LabelerName": "Direct_Rx",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260629",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25° C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene) -N ,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula. [Chemical Structure]. Cyclobenzaprine hydrochloride tablets, USP for oral administration, are available in the following strengths, 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&C yellow #6, and both the 5 mg and 10 mg tablets contain iron oxide yellow."
},
{
"NDCCode": "42291-016-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-016-90) ",
"NDC11Code": "42291-0016-90",
"ProductNDC": "42291-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079220",
"LabelerName": "AvKARE",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230206",
"SamplePackage": "N",
"IndicationAndUsage": "Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3) .",
"Description": "Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5 and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "42291-027-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-027-90) ",
"NDC11Code": "42291-0027-90",
"ProductNDC": "42291-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076846",
"LabelerName": "AvKARE",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42291-036-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-036-90) ",
"NDC11Code": "42291-0036-90",
"ProductNDC": "42291-036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-037-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-037-90) ",
"NDC11Code": "42291-0037-90",
"ProductNDC": "42291-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-038-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-038-90) ",
"NDC11Code": "42291-0038-90",
"ProductNDC": "42291-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-039-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-039-90) ",
"NDC11Code": "42291-0039-90",
"ProductNDC": "42291-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-040-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-040-90) ",
"NDC11Code": "42291-0040-90",
"ProductNDC": "42291-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-041-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-041-90) ",
"NDC11Code": "42291-0041-90",
"ProductNDC": "42291-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-045-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90) ",
"NDC11Code": "42291-0045-90",
"ProductNDC": "42291-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204598",
"LabelerName": "AvKARE",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets are peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). For treatment of adult patients with severe hypertriglyceridemia ( 1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1).",
"Description": "Fenofibrate tablets, USP are lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula. The empirical formula is C20H21ClO4 and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum."
},
{
"NDCCode": "42291-085-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90) ",
"NDC11Code": "42291-0085-90",
"ProductNDC": "42291-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078058",
"LabelerName": "AvKARE",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200923",
"SamplePackage": "N",
"IndicationAndUsage": "Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. ( 1.3) .",
"Description": "Anastrozole Tablets USP for oral administration contain 1 mg of anastrozole, USP, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, α, α, α', α'-tetramethyl-5-(1 H-1,2,4-triazol-1-ylmethyl). Its structural formula is:. C 17H 19N 5 M.W. 293.37. Anastrozole, USP is a white to off-white crystalline powder. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C), is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "42291-101-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-101-90) ",
"NDC11Code": "42291-0101-90",
"ProductNDC": "42291-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acebutolol Hydrochloride",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075047",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N"
},
{
"NDCCode": "42291-102-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-102-90) ",
"NDC11Code": "42291-0102-90",
"ProductNDC": "42291-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acebutolol Hydrochloride",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075047",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N"
},
{
"NDCCode": "42291-103-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-103-90)",
"NDC11Code": "42291-0103-90",
"ProductNDC": "42291-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084840",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "42291-108-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-108-90) ",
"NDC11Code": "42291-0108-90",
"ProductNDC": "42291-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42291-109-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-109-90) ",
"NDC11Code": "42291-0109-90",
"ProductNDC": "42291-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42291-118-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-118-90) ",
"NDC11Code": "42291-0118-90",
"ProductNDC": "42291-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiodarone Hydrochloride",
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075424",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "AMIODARONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170125",
"SamplePackage": "N"
},
{
"NDCCode": "42291-122-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-122-90) ",
"NDC11Code": "42291-0122-90",
"ProductNDC": "42291-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiloride Hydrochloride",
"NonProprietaryName": "Amiloride Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079133",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "AMILORIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120328",
"SamplePackage": "N"
},
{
"NDCCode": "42291-125-90",
"PackageDescription": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-125-90)",
"NDC11Code": "42291-0125-90",
"ProductNDC": "42291-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hcl",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078720",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42291-680-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-680-90)</PackageDescription>
<NDC11Code>42291-0680-90</NDC11Code>
<ProductNDC>42291-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091450</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>21695-680-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (21695-680-90)</PackageDescription>
<NDC11Code>21695-0680-90</NDC11Code>
<ProductNDC>21695-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040901</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>33261-680-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-680-90)</PackageDescription>
<NDC11Code>33261-0680-90</NDC11Code>
<ProductNDC>33261-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077284</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Seasonal Affective Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder. The efficacy of bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see CLINICAL TRIALS). Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150-mg and 300-mg, round white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: dehydrated alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, hydrogenated vegetable oil and ethyl alcohol. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP drug release testing is pending.</Description>
</NDC>
<NDC>
<NDCCode>35356-680-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (35356-680-90)</PackageDescription>
<NDC11Code>35356-0680-90</NDC11Code>
<ProductNDC>35356-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073554</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41250-680-75</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-680-75) / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0680-75</NDC11Code>
<ProductNDC>41250-680</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074661</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:minor pain of arthritismuscular achesbackachemenstrual crampsheadachetoothachethe common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51655-680-26</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-680-26) </PackageDescription>
<NDC11Code>51655-0680-26</NDC11Code>
<ProductNDC>51655-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated round and capsule shaped tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copovidone, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the peach (10 mg) and light pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>58980-680-90</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (58980-680-90) > 255 g in 1 TUBE</PackageDescription>
<NDC11Code>58980-0680-90</NDC11Code>
<ProductNDC>58980-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remeven</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080618</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharmaceuticals, Inc</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>71</StrengthNumber>
<StrengthUnit>g/142g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>62135-680-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-680-90) </PackageDescription>
<NDC11Code>62135-0680-90</NDC11Code>
<ProductNDC>62135-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>63187-680-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-680-90) </PackageDescription>
<NDC11Code>63187-0680-90</NDC11Code>
<ProductNDC>63187-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072192</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Trazodone hydrochloride is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water. Chemical Name: 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride. Structural Formula. Molecular Formula: C19H22ClN5OHCl. Molecular Weight: 408.32. Each tablet, for oral administration, contains 50 mg or 100 mg of trazodone hydrochloride, USP. In addition, each tablet contains hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-680-90</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (65162-680-90) </PackageDescription>
<NDC11Code>65162-0680-90</NDC11Code>
<ProductNDC>65162-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090575</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>6.25; 15</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide USP, 15 mg; promethazine hydrochloride USP, 6.25 mg. Alcohol 7%. Inactive Ingredients: ascorbic acid, citric acid, edetate disodium, FD&C Yellow #6, glycerin, methylparaben, natural & artificial flavors, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Dextromethorphan hydrobromide, USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α,13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide, USP occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH20, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as "10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride". Promethazine hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S HCl, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>71610-680-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-680-60) </PackageDescription>
<NDC11Code>71610-0680-60</NDC11Code>
<ProductNDC>71610-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074497</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide Tablets USP are an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[ p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide Tablets USP for oral use are available in 5 and 10 mg strengths. Each tablet contains the following inactive ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinized corn starch; silicon dioxide; stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>72189-680-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72189-680-90) </PackageDescription>
<NDC11Code>72189-0680-90</NDC11Code>
<ProductNDC>72189-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hcl</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077563</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25° C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene) -N ,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula. [Chemical Structure]. Cyclobenzaprine hydrochloride tablets, USP for oral administration, are available in the following strengths, 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&C yellow #6, and both the 5 mg and 10 mg tablets contain iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>42291-016-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-016-90) </PackageDescription>
<NDC11Code>42291-0016-90</NDC11Code>
<ProductNDC>42291-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079220</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5 and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-027-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-027-90) </PackageDescription>
<NDC11Code>42291-0027-90</NDC11Code>
<ProductNDC>42291-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076846</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42291-036-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-036-90) </PackageDescription>
<NDC11Code>42291-0036-90</NDC11Code>
<ProductNDC>42291-036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-037-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-037-90) </PackageDescription>
<NDC11Code>42291-0037-90</NDC11Code>
<ProductNDC>42291-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-038-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-038-90) </PackageDescription>
<NDC11Code>42291-0038-90</NDC11Code>
<ProductNDC>42291-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-039-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-039-90) </PackageDescription>
<NDC11Code>42291-0039-90</NDC11Code>
<ProductNDC>42291-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-040-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-040-90) </PackageDescription>
<NDC11Code>42291-0040-90</NDC11Code>
<ProductNDC>42291-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-041-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-041-90) </PackageDescription>
<NDC11Code>42291-0041-90</NDC11Code>
<ProductNDC>42291-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-045-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90) </PackageDescription>
<NDC11Code>42291-0045-90</NDC11Code>
<ProductNDC>42291-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204598</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). For treatment of adult patients with severe hypertriglyceridemia ( 1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1).</IndicationAndUsage>
<Description>Fenofibrate tablets, USP are lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula. The empirical formula is C20H21ClO4 and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
</NDC>
<NDC>
<NDCCode>42291-085-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90) </PackageDescription>
<NDC11Code>42291-0085-90</NDC11Code>
<ProductNDC>42291-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078058</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole Tablets USP for oral administration contain 1 mg of anastrozole, USP, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, α, α, α', α'-tetramethyl-5-(1 H-1,2,4-triazol-1-ylmethyl). Its structural formula is:. C 17H 19N 5 M.W. 293.37. Anastrozole, USP is a white to off-white crystalline powder. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C), is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-101-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-101-90) </PackageDescription>
<NDC11Code>42291-0101-90</NDC11Code>
<ProductNDC>42291-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075047</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-102-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-102-90) </PackageDescription>
<NDC11Code>42291-0102-90</NDC11Code>
<ProductNDC>42291-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075047</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-103-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-103-90)</PackageDescription>
<NDC11Code>42291-0103-90</NDC11Code>
<ProductNDC>42291-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084840</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-108-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-108-90) </PackageDescription>
<NDC11Code>42291-0108-90</NDC11Code>
<ProductNDC>42291-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42291-109-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-109-90) </PackageDescription>
<NDC11Code>42291-0109-90</NDC11Code>
<ProductNDC>42291-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42291-118-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-118-90) </PackageDescription>
<NDC11Code>42291-0118-90</NDC11Code>
<ProductNDC>42291-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
<NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075424</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-122-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-122-90) </PackageDescription>
<NDC11Code>42291-0122-90</NDC11Code>
<ProductNDC>42291-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiloride Hydrochloride</ProprietaryName>
<NonProprietaryName>Amiloride Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079133</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>AMILORIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-125-90</NDCCode>
<PackageDescription>90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-125-90)</PackageDescription>
<NDC11Code>42291-0125-90</NDC11Code>
<ProductNDC>42291-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hcl</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078720</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
</NDCList>