{
"NDC": [
{
"NDCCode": "42043-371-90",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42043-371-90)",
"NDC11Code": "42043-0371-90",
"ProductNDC": "42043-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantooprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202052",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "42043-371-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42043-371-01)",
"NDC11Code": "42043-0371-01",
"ProductNDC": "42043-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantooprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202052",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "42043-160-90",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42043-160-90) > 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "42043-0160-90",
"ProductNDC": "42043-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Modafinil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078963",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130801",
"SamplePackage": "N",
"IndicationAndUsage": "Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of UseIn OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.",
"Description": "Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. USP dissolution test pending."
},
{
"NDCCode": "42043-161-90",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42043-161-90) > 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "42043-0161-90",
"ProductNDC": "42043-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Modafinil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078963",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130801",
"SamplePackage": "N",
"IndicationAndUsage": "Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of UseIn OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.",
"Description": "Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. USP dissolution test pending."
},
{
"NDCCode": "42043-170-09",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (42043-170-09)",
"NDC11Code": "42043-0170-09",
"ProductNDC": "42043-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076520",
"LabelerName": "Karalex Pharma LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42043-171-09",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (42043-171-09)",
"NDC11Code": "42043-0171-09",
"ProductNDC": "42043-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076520",
"LabelerName": "Karalex Pharma LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42043-370-90",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42043-370-90)",
"NDC11Code": "42043-0370-90",
"ProductNDC": "42043-370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202052",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "21695-371-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (21695-371-90)",
"NDC11Code": "21695-0371-90",
"ProductNDC": "21695-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070925",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clonidine hydrochloride USP tablets are indicated in the treatment of hypertension. Clonidine hydrochloride USP tablets may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "43063-371-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-90) ",
"NDC11Code": "43063-0371-90",
"ProductNDC": "43063-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090844",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120723",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets are P2Y 12platelet inhibitor indicated for:. ● Acute coronary syndrome. – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1). – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.1). ● Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.2).",
"Description": "Clopidogrel tablets, USP are a thienopyridine class inhibitor of P2Y 12ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5( 4H)acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration are provided as light pink colored, round, beveled edge, biconvex, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The light pink film coating contains ferric oxide red, hypromellose 2910, and titanium dioxide."
},
{
"NDCCode": "52125-371-19",
"PackageDescription": "90 TABLET in 1 BOTTLE (52125-371-19)",
"NDC11Code": "52125-0371-19",
"ProductNDC": "52125-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077955",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "53217-371-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (53217-371-90) ",
"NDC11Code": "53217-0371-90",
"ProductNDC": "53217-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076004",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180402",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:Osteoarthritis Rheumatoid arthritis , 2 For the management of acute pain .",
"Description": "Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula:. Each etodolac tablet, USP is for oral administration, contains 400 mg or 500 mg of etodolac. In addition, each tablet contains the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "59746-371-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59746-371-90) ",
"NDC11Code": "59746-0371-90",
"ProductNDC": "59746-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felodipine",
"NonProprietaryName": "Felodipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203983",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "FELODIPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160819",
"SamplePackage": "N"
},
{
"NDCCode": "63187-371-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63187-371-90) ",
"NDC11Code": "63187-0371-90",
"ProductNDC": "63187-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202433",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160901",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride USP is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is: Each tamsulosin hydrochloride capsule, USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: calcium stearate, FD&C Blue 2, gelatin, iron oxide red, iron oxide yellow, microcrystalline cellulose, methacrylic acid copolymer dispersion, sodium lauryl sulfate, talc, triacetin, and titanium dioxide. The capsules are printed with SW-9008 Black Ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.Meets USP dissolution test 10."
},
{
"NDCCode": "65162-371-09",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-09) ",
"NDC11Code": "65162-0371-09",
"ProductNDC": "65162-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204010",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151102",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).",
"Description": "Oxybutynin chloride, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride, USP is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride, USP is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets, USP also contains the following inert ingredients: hydrogenated vegetable oil, hypromellose, isopropyl alcohol, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium lauryl sulfate, talc and triethyl citrate. The 5 mg tablets also contain D&C Red #27 and FD&C Blue #1. The 10 mg tablets also contain FD&C Red #40 and FD&C Yellow #6. Meets USP Dissolution Test 7. System Components and Performance. Oxybutynin chloride extended-release tablet, USP uses a pH-independent hydrophilic matrix and pH dependent enteric coating to deliver oxybutynin chloride, USP at a controlled rate over approximately 24 hours. The oxybutynin chloride extended-release tablet, USP comprises of an inner core made of the drug, rate controlling pH independent polymer and other excipients. The tablet core is then coated with pH dependent enteric coating polymer. When tablets will be exposed to an acidic environment such as the stomach, the drug release will be minimal due to outer enteric coating of the pH dependent polymer. The outer enteric coating upon reaching an environment of pH 5.5 and above will start to dissolve and the polymer in the inner core tablet will hydrate to form a gel layer and the drug releases via diffusion process."
},
{
"NDCCode": "67544-371-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (67544-371-60)",
"NDC11Code": "67544-0371-60",
"ProductNDC": "67544-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030627",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075798",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol is indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)., 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present., 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.",
"Description": "Allopurinol has the following structural formula. Allopurinol is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allopurinol and the inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Each scored orange tablet contains 300 mg allopurinol and the inactive ingredients colloidal silicon dioxide, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Its solubility in water at 37°C is 80 mg/dL and is greater in an alkaline solution."
},
{
"NDCCode": "68405-198-36",
"PackageDescription": "1 KIT in 1 KIT (68405-198-36) * 90 CAPSULE in 1 BOTTLE * 60 TABLET in 1 BOTTLE (52959-371-60)",
"NDC11Code": "68405-0198-36",
"ProductNDC": "68405-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Theracodophen-650",
"NonProprietaryName": "Hydrocodone Bitartrate, Acetaminophen, .gamma.-aminobutyric Acid",
"DosageFormName": "KIT",
"StartMarketingDate": "20110306",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Physician Therapeutics LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68462-371-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-371-90) ",
"NDC11Code": "68462-0371-90",
"ProductNDC": "68462-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210278",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Extended-Release Capsules are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36 g/mol. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate Extended-Release Capsules contain pellets of topiramate, USP in a capsule. The inactive ingredients are D&C red No.30, ethylcellulose, FD&C red No.40, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell for Topiramate Extended-Release Capsules, 25 mg contains black iron oxide, hypromellose, red iron oxide and titanium dioxide. The capsule shell for Topiramate Extended-Release Capsules, 50 mg contains black iron oxide, hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide. The capsule shell for Topiramate Extended-Release Capsules, 100 mg contains black iron oxide, hypromellose, red iron oxide and titanium dioxide. The capsule shell for Topiramate Extended-Release Capsules, 150 mg contains black iron oxide, hypromellose, and titanium dioxide. The capsule shell for Topiramate Extended-Release Capsules, 200 mg contains black iron oxide, hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink has the following components: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "68682-371-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68682-371-90) ",
"NDC11Code": "68682-0371-90",
"ProductNDC": "68682-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020401",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Diltiazem hydrochloride extended-release capsules, USP also contain: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. USP Drug Release Test 6. For oral administration."
},
{
"NDCCode": "71205-371-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (71205-371-90) ",
"NDC11Code": "71205-0371-90",
"ProductNDC": "71205-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074891",
"LabelerName": "Proficient Rx LP",
"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 [EXT]",
"Status": "Active",
"LastUpdate": "2022-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir tablets, USP is a formulation for oral administration. Each tablet for oral administration contains 400 mg or 800 mg of acyclovir, USP. In addition each tablet contains the following inactive ingredients, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities. The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance. Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
"NDCCode": "72789-371-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-371-90) ",
"NDC11Code": "72789-0371-90",
"ProductNDC": "72789-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205150",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240123",
"SamplePackage": "N",
"Description": "Telmisartan tablets USP is a non-peptide angiotensin II receptor (type AT 1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33H 30N 4O 2, its molecular weight is 514.63, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and sodium streayl fumarate. Telmisartan tablets, USP are hygroscopic and require protection from moisture."
},
{
"NDCCode": "42043-130-09",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (42043-130-09) > 9 TABLET, FILM COATED in 1 BLISTER PACK (42043-130-00) ",
"NDC11Code": "42043-0130-09",
"ProductNDC": "42043-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091441",
"LabelerName": "OrchidPharma, Inc",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20121212",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2."
},
{
"NDCCode": "42043-131-09",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (42043-131-09) > 9 TABLET, FILM COATED in 1 BLISTER PACK (42043-131-00) ",
"NDC11Code": "42043-0131-09",
"ProductNDC": "42043-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091441",
"LabelerName": "OrchidPharma, Inc",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20121212",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2."
},
{
"NDCCode": "42043-410-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42043-410-01) ",
"NDC11Code": "42043-0410-01",
"ProductNDC": "42043-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terbinafine Hydrochloride",
"NonProprietaryName": "Terbinafine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078163",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "TERBINAFINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.",
"Description": "Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride, USP. Chemically, terbinafine hydrochloride, USP is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26ClN with a molecular weight of 327.90, and the following structural formula. Terbinafine hydrochloride, USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water. Each tablet contains:. Active Ingredient: terbinafine hydrochloride, USP (equivalent to 250 mg terbinafine). Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42043-410-03",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (42043-410-03) ",
"NDC11Code": "42043-0410-03",
"ProductNDC": "42043-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terbinafine Hydrochloride",
"NonProprietaryName": "Terbinafine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078163",
"LabelerName": "OrchidPharma Inc",
"SubstanceName": "TERBINAFINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.",
"Description": "Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride, USP. Chemically, terbinafine hydrochloride, USP is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26ClN with a molecular weight of 327.90, and the following structural formula. Terbinafine hydrochloride, USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water. Each tablet contains:. Active Ingredient: terbinafine hydrochloride, USP (equivalent to 250 mg terbinafine). Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42806-371-30",
"PackageDescription": "30 PACKET in 1 CARTON (42806-371-30) / 1 GRANULE in 1 PACKET",
"NDC11Code": "42806-0371-30",
"ProductNDC": "42806-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox Oral Granules",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214559",
"LabelerName": "EPIC PHARMA, LLC",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221006",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox oral granules is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1). Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion- dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. ( 1.2). Limitations of Use:. The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established. ( 1.3).",
"Description": "Deferasirox is an iron-chelating agent provided as granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl] benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox Oral Granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, silicon dioxide."
},
{
"NDCCode": "70748-371-02",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70748-371-02) / 5 mL in 1 VIAL, SINGLE-DOSE (70748-371-01) ",
"NDC11Code": "70748-0371-02",
"ProductNDC": "70748-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214338",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl) - 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin Octa sodium salt with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear and colorless to slightly brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.785 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "72205-371-91",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72205-371-91) ",
"NDC11Code": "72205-0371-91",
"ProductNDC": "72205-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol Hydrochloride",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220865",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260903",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C14H24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red."
},
{
"NDCCode": "72647-371-30",
"PackageDescription": "30 PACKET in 1 CARTON (72647-371-30) > 1 GRANULE in 1 PACKET",
"NDC11Code": "72647-0371-30",
"ProductNDC": "72647-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox Oral Granules",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210309",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214559",
"LabelerName": "OAKRUM PHARMA, LLC",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210309",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox oral granules is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion- dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron-chelating agent provided as granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl] benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox Oral Granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, silicon dioxide."
},
{
"NDCCode": "87063-287-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (87063-287-90) ",
"NDC11Code": "87063-0287-90",
"ProductNDC": "87063-287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "87063-288-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (87063-288-90) ",
"NDC11Code": "87063-0288-90",
"ProductNDC": "87063-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
}
]
}
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<NDCList>
<NDC>
<NDCCode>42043-371-90</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42043-371-90)</PackageDescription>
<NDC11Code>42043-0371-90</NDC11Code>
<ProductNDC>42043-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantooprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202052</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42043-371-01</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42043-371-01)</PackageDescription>
<NDC11Code>42043-0371-01</NDC11Code>
<ProductNDC>42043-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantooprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202052</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42043-160-90</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42043-160-90) > 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>42043-0160-90</NDC11Code>
<ProductNDC>42043-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Modafinil</ProprietaryName>
<NonProprietaryName>Modafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078963</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of UseIn OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>42043-161-90</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42043-161-90) > 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>42043-0161-90</NDC11Code>
<ProductNDC>42043-161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Modafinil</ProprietaryName>
<NonProprietaryName>Modafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078963</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of UseIn OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>42043-170-09</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (42043-170-09)</PackageDescription>
<NDC11Code>42043-0170-09</NDC11Code>
<ProductNDC>42043-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076520</ApplicationNumber>
<LabelerName>Karalex Pharma LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42043-171-09</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (42043-171-09)</PackageDescription>
<NDC11Code>42043-0171-09</NDC11Code>
<ProductNDC>42043-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076520</ApplicationNumber>
<LabelerName>Karalex Pharma LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42043-370-90</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42043-370-90)</PackageDescription>
<NDC11Code>42043-0370-90</NDC11Code>
<ProductNDC>42043-370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202052</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21695-371-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (21695-371-90)</PackageDescription>
<NDC11Code>21695-0371-90</NDC11Code>
<ProductNDC>21695-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070925</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clonidine hydrochloride USP tablets are indicated in the treatment of hypertension. Clonidine hydrochloride USP tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>43063-371-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-371-90) </PackageDescription>
<NDC11Code>43063-0371-90</NDC11Code>
<ProductNDC>43063-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090844</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets are P2Y 12platelet inhibitor indicated for:. ● Acute coronary syndrome. – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1). – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.1). ● Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. ( 1.2).</IndicationAndUsage>
<Description>Clopidogrel tablets, USP are a thienopyridine class inhibitor of P2Y 12ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5( 4H)acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration are provided as light pink colored, round, beveled edge, biconvex, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The light pink film coating contains ferric oxide red, hypromellose 2910, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52125-371-19</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (52125-371-19)</PackageDescription>
<NDC11Code>52125-0371-19</NDC11Code>
<ProductNDC>52125-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077955</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>53217-371-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (53217-371-90) </PackageDescription>
<NDC11Code>53217-0371-90</NDC11Code>
<ProductNDC>53217-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076004</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:Osteoarthritis Rheumatoid arthritis , 2 For the management of acute pain .</IndicationAndUsage>
<Description>Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula:. Each etodolac tablet, USP is for oral administration, contains 400 mg or 500 mg of etodolac. In addition, each tablet contains the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59746-371-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59746-371-90) </PackageDescription>
<NDC11Code>59746-0371-90</NDC11Code>
<ProductNDC>59746-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felodipine</ProprietaryName>
<NonProprietaryName>Felodipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203983</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FELODIPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-371-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63187-371-90) </PackageDescription>
<NDC11Code>63187-0371-90</NDC11Code>
<ProductNDC>63187-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202433</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride USP is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C20H28N2O5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is: Each tamsulosin hydrochloride capsule, USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: calcium stearate, FD&C Blue 2, gelatin, iron oxide red, iron oxide yellow, microcrystalline cellulose, methacrylic acid copolymer dispersion, sodium lauryl sulfate, talc, triacetin, and titanium dioxide. The capsules are printed with SW-9008 Black Ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.Meets USP dissolution test 10.</Description>
</NDC>
<NDC>
<NDCCode>65162-371-09</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-09) </PackageDescription>
<NDC11Code>65162-0371-09</NDC11Code>
<ProductNDC>65162-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204010</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).</IndicationAndUsage>
<Description>Oxybutynin chloride, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride, USP is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride, USP is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets, USP also contains the following inert ingredients: hydrogenated vegetable oil, hypromellose, isopropyl alcohol, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium lauryl sulfate, talc and triethyl citrate. The 5 mg tablets also contain D&C Red #27 and FD&C Blue #1. The 10 mg tablets also contain FD&C Red #40 and FD&C Yellow #6. Meets USP Dissolution Test 7. System Components and Performance. Oxybutynin chloride extended-release tablet, USP uses a pH-independent hydrophilic matrix and pH dependent enteric coating to deliver oxybutynin chloride, USP at a controlled rate over approximately 24 hours. The oxybutynin chloride extended-release tablet, USP comprises of an inner core made of the drug, rate controlling pH independent polymer and other excipients. The tablet core is then coated with pH dependent enteric coating polymer. When tablets will be exposed to an acidic environment such as the stomach, the drug release will be minimal due to outer enteric coating of the pH dependent polymer. The outer enteric coating upon reaching an environment of pH 5.5 and above will start to dissolve and the polymer in the inner core tablet will hydrate to form a gel layer and the drug releases via diffusion process.</Description>
</NDC>
<NDC>
<NDCCode>67544-371-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (67544-371-60)</PackageDescription>
<NDC11Code>67544-0371-60</NDC11Code>
<ProductNDC>67544-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030627</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075798</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol is indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)., 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present., 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.</IndicationAndUsage>
<Description>Allopurinol has the following structural formula. Allopurinol is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allopurinol and the inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Each scored orange tablet contains 300 mg allopurinol and the inactive ingredients colloidal silicon dioxide, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Its solubility in water at 37°C is 80 mg/dL and is greater in an alkaline solution.</Description>
</NDC>
<NDC>
<NDCCode>68405-198-36</NDCCode>
<PackageDescription>1 KIT in 1 KIT (68405-198-36) * 90 CAPSULE in 1 BOTTLE * 60 TABLET in 1 BOTTLE (52959-371-60)</PackageDescription>
<NDC11Code>68405-0198-36</NDC11Code>
<ProductNDC>68405-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Theracodophen-650</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate, Acetaminophen, .gamma.-aminobutyric Acid</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110306</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Physician Therapeutics LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68462-371-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-371-90) </PackageDescription>
<NDC11Code>68462-0371-90</NDC11Code>
<ProductNDC>68462-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210278</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Extended-Release Capsules are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36 g/mol. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate Extended-Release Capsules contain pellets of topiramate, USP in a capsule. The inactive ingredients are D&C red No.30, ethylcellulose, FD&C red No.40, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell for Topiramate Extended-Release Capsules, 25 mg contains black iron oxide, hypromellose, red iron oxide and titanium dioxide. The capsule shell for Topiramate Extended-Release Capsules, 50 mg contains black iron oxide, hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide. The capsule shell for Topiramate Extended-Release Capsules, 100 mg contains black iron oxide, hypromellose, red iron oxide and titanium dioxide. The capsule shell for Topiramate Extended-Release Capsules, 150 mg contains black iron oxide, hypromellose, and titanium dioxide. The capsule shell for Topiramate Extended-Release Capsules, 200 mg contains black iron oxide, hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink has the following components: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>68682-371-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68682-371-90) </PackageDescription>
<NDC11Code>68682-0371-90</NDC11Code>
<ProductNDC>68682-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Diltiazem hydrochloride extended-release capsules, USP also contain: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. USP Drug Release Test 6. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>71205-371-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71205-371-90) </PackageDescription>
<NDC11Code>71205-0371-90</NDC11Code>
<ProductNDC>71205-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074891</ApplicationNumber>
<LabelerName>Proficient Rx LP</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 [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir tablets, USP is a formulation for oral administration. Each tablet for oral administration contains 400 mg or 800 mg of acyclovir, USP. In addition each tablet contains the following inactive ingredients, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities. The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance. Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>72789-371-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (72789-371-90) </PackageDescription>
<NDC11Code>72789-0371-90</NDC11Code>
<ProductNDC>72789-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205150</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Telmisartan tablets USP is a non-peptide angiotensin II receptor (type AT 1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33H 30N 4O 2, its molecular weight is 514.63, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and sodium streayl fumarate. Telmisartan tablets, USP are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>42043-130-09</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (42043-130-09) > 9 TABLET, FILM COATED in 1 BLISTER PACK (42043-130-00) </PackageDescription>
<NDC11Code>42043-0130-09</NDC11Code>
<ProductNDC>42043-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091441</ApplicationNumber>
<LabelerName>OrchidPharma, Inc</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2.</Description>
</NDC>
<NDC>
<NDCCode>42043-131-09</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (42043-131-09) > 9 TABLET, FILM COATED in 1 BLISTER PACK (42043-131-00) </PackageDescription>
<NDC11Code>42043-0131-09</NDC11Code>
<ProductNDC>42043-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091441</ApplicationNumber>
<LabelerName>OrchidPharma, Inc</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use. : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2.</Description>
</NDC>
<NDC>
<NDCCode>42043-410-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42043-410-01) </PackageDescription>
<NDC11Code>42043-0410-01</NDC11Code>
<ProductNDC>42043-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terbinafine Hydrochloride</ProprietaryName>
<NonProprietaryName>Terbinafine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078163</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>TERBINAFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.</IndicationAndUsage>
<Description>Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride, USP. Chemically, terbinafine hydrochloride, USP is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26ClN with a molecular weight of 327.90, and the following structural formula. Terbinafine hydrochloride, USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water. Each tablet contains:. Active Ingredient: terbinafine hydrochloride, USP (equivalent to 250 mg terbinafine). Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42043-410-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (42043-410-03) </PackageDescription>
<NDC11Code>42043-0410-03</NDC11Code>
<ProductNDC>42043-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terbinafine Hydrochloride</ProprietaryName>
<NonProprietaryName>Terbinafine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078163</ApplicationNumber>
<LabelerName>OrchidPharma Inc</LabelerName>
<SubstanceName>TERBINAFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.</IndicationAndUsage>
<Description>Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride, USP. Chemically, terbinafine hydrochloride, USP is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26ClN with a molecular weight of 327.90, and the following structural formula. Terbinafine hydrochloride, USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water. Each tablet contains:. Active Ingredient: terbinafine hydrochloride, USP (equivalent to 250 mg terbinafine). Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42806-371-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (42806-371-30) / 1 GRANULE in 1 PACKET</PackageDescription>
<NDC11Code>42806-0371-30</NDC11Code>
<ProductNDC>42806-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox Oral Granules</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214559</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox oral granules is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1). Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion- dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. ( 1.2). Limitations of Use:. The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established. ( 1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron-chelating agent provided as granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl] benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox Oral Granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-371-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70748-371-02) / 5 mL in 1 VIAL, SINGLE-DOSE (70748-371-01) </PackageDescription>
<NDC11Code>70748-0371-02</NDC11Code>
<ProductNDC>70748-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214338</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl) - 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin Octa sodium salt with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear and colorless to slightly brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.785 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>72205-371-91</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (72205-371-91) </PackageDescription>
<NDC11Code>72205-0371-91</NDC11Code>
<ProductNDC>72205-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220865</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C14H24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>72647-371-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (72647-371-30) > 1 GRANULE in 1 PACKET</PackageDescription>
<NDC11Code>72647-0371-30</NDC11Code>
<ProductNDC>72647-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox Oral Granules</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210309</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214559</ApplicationNumber>
<LabelerName>OAKRUM PHARMA, LLC</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210309</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox oral granules is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion- dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron-chelating agent provided as granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl] benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox Oral Granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-287-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (87063-287-90) </PackageDescription>
<NDC11Code>87063-0287-90</NDC11Code>
<ProductNDC>87063-287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>87063-288-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (87063-288-90) </PackageDescription>
<NDC11Code>87063-0288-90</NDC11Code>
<ProductNDC>87063-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT 1B/1Dreceptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:. The empirical formula is C 17H 25N 3O 2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
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