{
"NDC": [
{
"NDCCode": "59922-643-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (59922-643-60) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "59922-0643-60",
"ProductNDC": "59922-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vafseo",
"NonProprietaryName": "Vadadustat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215192",
"LabelerName": "Akebia Therapeutics, Inc.",
"SubstanceName": "VADADUSTAT",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC], Organic Anion Transporter 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use: 1 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being., 2 VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)].",
"Description": "VAFSEO contains vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Vadadustat is 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid. Vadadustat has a molecular weight of 306.70. The empirical formula is C14H11ClN2O4. The chemical structure is. Vadadustat is a white to off-white solid that is practically insoluble in water. Vadadustat is formulated as a film-coated, immediate-release tablet for oral administration. VAFSEO is available in 150 mg, 300 mg and 450 mg strengths. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc. Colorants include:150 mg tablet - titanium dioxide300 mg tablet - titanium dioxide and yellow iron oxide450 mg tablet - titanium dioxide, iron oxide red and ferrosoferric oxide."
},
{
"NDCCode": "59922-641-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (59922-641-60) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "59922-0641-60",
"ProductNDC": "59922-641",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vafseo",
"NonProprietaryName": "Vadadustat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215192",
"LabelerName": "Akebia Therapeutics, Inc.",
"SubstanceName": "VADADUSTAT",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC], Organic Anion Transporter 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use: 1 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being., 2 VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)].",
"Description": "VAFSEO contains vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Vadadustat is 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid. Vadadustat has a molecular weight of 306.70. The empirical formula is C14H11ClN2O4. The chemical structure is. Vadadustat is a white to off-white solid that is practically insoluble in water. Vadadustat is formulated as a film-coated, immediate-release tablet for oral administration. VAFSEO is available in 150 mg, 300 mg and 450 mg strengths. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc. Colorants include:150 mg tablet - titanium dioxide300 mg tablet - titanium dioxide and yellow iron oxide450 mg tablet - titanium dioxide, iron oxide red and ferrosoferric oxide."
},
{
"NDCCode": "59922-642-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (59922-642-60) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "59922-0642-60",
"ProductNDC": "59922-642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vafseo",
"NonProprietaryName": "Vadadustat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215192",
"LabelerName": "Akebia Therapeutics, Inc.",
"SubstanceName": "VADADUSTAT",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC], Organic Anion Transporter 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use: 1 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being., 2 VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)].",
"Description": "VAFSEO contains vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Vadadustat is 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid. Vadadustat has a molecular weight of 306.70. The empirical formula is C14H11ClN2O4. The chemical structure is. Vadadustat is a white to off-white solid that is practically insoluble in water. Vadadustat is formulated as a film-coated, immediate-release tablet for oral administration. VAFSEO is available in 150 mg, 300 mg and 450 mg strengths. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc. Colorants include:150 mg tablet - titanium dioxide300 mg tablet - titanium dioxide and yellow iron oxide450 mg tablet - titanium dioxide, iron oxide red and ferrosoferric oxide."
},
{
"NDCCode": "16590-643-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-643-60)",
"NDC11Code": "16590-0643-60",
"ProductNDC": "16590-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078881",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed."
},
{
"NDCCode": "21695-643-60",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (21695-643-60)",
"NDC11Code": "21695-0643-60",
"ProductNDC": "21695-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20050628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065148",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC],Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid for pH adjustment."
},
{
"NDCCode": "35356-643-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (35356-643-60)",
"NDC11Code": "35356-0643-60",
"ProductNDC": "35356-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090964",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2016-12-22"
},
{
"NDCCode": "42549-643-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42549-643-60)",
"NDC11Code": "42549-0643-60",
"ProductNDC": "42549-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077712",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "43353-643-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43353-643-60)",
"NDC11Code": "43353-0643-60",
"ProductNDC": "43353-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075743",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration."
},
{
"NDCCode": "43598-643-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-643-60) ",
"NDC11Code": "43598-0643-60",
"ProductNDC": "43598-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"ProprietaryNameSuffix": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213627",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250716",
"SamplePackage": "N",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are calcium carbonate, crospovidone, magnesium stearate, microcrystalline cellulose, polysorbate 80 and silicon dioxide. The film-coating material contains, diacetylated monoglycerides, hypromellose. Imprinting ink contains, ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "45865-643-60",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-60) ",
"NDC11Code": "45865-0643-60",
"ProductNDC": "45865-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110610",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020699",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150911",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "49035-643-60",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (49035-643-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "49035-0643-60",
"ProductNDC": "49035-643",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Allergy And Congestion Relief",
"NonProprietaryName": "Loratadine, Pseudoephedrine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076050",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"StrengthNumber": "5; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itchy, watery eyes. runny nose. itching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
},
{
"NDCCode": "51316-643-04",
"PackageDescription": "1 BOTTLE in 1 BOX (51316-643-04) / 60 mL in 1 BOTTLE",
"NDC11Code": "51316-0643-04",
"ProductNDC": "51316-643",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dye Free Infants Pain And Fever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "CVS",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250215",
"SamplePackage": "N",
"IndicationAndUsage": "Usestemporarily:. - reduces fever - relieves minor aches and pains due to: : 1 the common cold, 2 flu, 3 headache, 4 sore throat, 5 toothache."
},
{
"NDCCode": "52959-643-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (52959-643-60)",
"NDC11Code": "52959-0643-60",
"ProductNDC": "52959-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "58411-643-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-643-60) / 21 mL in 1 TUBE",
"NDC11Code": "58411-0643-60",
"ProductNDC": "58411-643",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Radiant Foundation N",
"ProprietaryNameSuffix": "O60",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.07; .3",
"StrengthUnit": "g/21mL; g/21mL",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "63187-643-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (63187-643-60) ",
"NDC11Code": "63187-0643-60",
"ProductNDC": "63187-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200562",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: sodium lauryl sulfate, edible inks, gelatin, lactose monohydrate, crospovidone, povidone and magnesium stearate."
},
{
"NDCCode": "66267-643-60",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOTTLE (66267-643-60) ",
"NDC11Code": "66267-0643-60",
"ProductNDC": "66267-643",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pluspharma",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20060327",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180320",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves bloating and pressure commonly referred to as gas."
},
{
"NDCCode": "68001-643-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68001-643-06) ",
"NDC11Code": "68001-0643-06",
"ProductNDC": "68001-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210203",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250418",
"SamplePackage": "N",
"Description": "Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine USP is a white or almost white powder. Capecitabine USP is freely soluble in anhydrous ethanol, sparingly soluble in water and practically insoluble in heptane. Capecitabine tablets, USP are supplied as oval shaped film-coated tablets for oral use. Each light peach colored tablet contains 150 mg capecitabine, USP and each light peach colored tablet contains 500 mg capecitabine, USP. The inactive ingredients in capecitabine tablets include: croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The peach or light peach film coating contains hypromellose, iron oxide red, iron oxide yellow, talc and titanium dioxide."
},
{
"NDCCode": "71205-643-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-643-60) ",
"NDC11Code": "71205-0643-60",
"ProductNDC": "71205-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220310",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7.Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
"NDCCode": "72189-643-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72189-643-60) ",
"NDC11Code": "72189-0643-60",
"ProductNDC": "72189-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078329",
"LabelerName": "Direct_Rx",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. [chem structure]. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide."
},
{
"NDCCode": "76420-643-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76420-643-60) ",
"NDC11Code": "76420-0643-60",
"ProductNDC": "76420-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210959",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231031",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the. Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1): Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.",
"Description": "Hydroxychloroquine is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate USP is a white or off-white to slightly yellowish color powder, freely soluble in water and practically insoluble in ethanol. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: crospovidone, lactose monohydrate and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "0168-0267-60",
"PackageDescription": "60 mL in 1 BOTTLE (0168-0267-60) ",
"NDC11Code": "00168-0267-60",
"ProductNDC": "0168-0267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "LOTION, AUGMENTED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077111",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070521",
"SamplePackage": "N",
"IndicationAndUsage": "Betamethasone dipropionate lotion (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.",
"Description": "Betamethasone Dipropionate Lotion USP (Augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. Each gram of betamethasone dipropionate lotion USP (augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion base of purified water, isopropyl alcohol (30%), phosphoric acid used to adjust the pH, hydroxypropyl cellulose, propylene glycol, and monobasic sodium phosphate (monohydrate)."
},
{
"NDCCode": "0430-3230-15",
"PackageDescription": "100 CARTON in 1 CASE (0430-3230-15) > 1 TUBE in 1 CARTON > 60 g in 1 TUBE",
"NDC11Code": "00430-3230-15",
"ProductNDC": "0430-3230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021852",
"LabelerName": "Warner Chilcott (US), LLC",
"SubstanceName": "CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .643",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-08-15"
},
{
"NDCCode": "0430-3240-15",
"PackageDescription": "30 CARTON in 1 CASE (0430-3240-15) > 1 BOTTLE in 1 CARTON > 60 g in 1 BOTTLE",
"NDC11Code": "00430-3240-15",
"ProductNDC": "0430-3240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taclonex Scalp",
"NonProprietaryName": "Calcipotriene 0.005% And Betamethasone Dipropionate 0.064%",
"DosageFormName": "SPRAY, METERED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022185",
"LabelerName": "Warner Chilcott (US), LLC",
"SubstanceName": "CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .643",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-08-15"
},
{
"NDCCode": "0713-0848-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLE",
"NDC11Code": "00713-0848-60",
"ProductNDC": "0713-0848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210765",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2024-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240802",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Calcipotriene and betamethasone dipropionate topical suspension contains calcipotriene and betamethasone dipropionate. It is for topical use only. Calcipotriene is a synthetic vitamin D 3analog. Calcipotriene. Calcipotriene is a vitamin D analog and has the chemical name (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.3, and the following structural formula (calcipotriene is a white to almost white, crystalline compound):. Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21- bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C 28H 37FO 7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder):. Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of calcipotriene and betamethasone dipropionate topical suspension contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, mineral oil and polyoxypropylene stearyl ether. Calcipotriene and betamethasone dipropionate topical suspension is an odorless clear to slightly off-white suspension."
},
{
"NDCCode": "0713-0848-92",
"PackageDescription": "2 BOTTLE in 1 CARTON (0713-0848-92) / 60 g in 1 BOTTLE",
"NDC11Code": "00713-0848-92",
"ProductNDC": "0713-0848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210765",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2024-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240802",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Calcipotriene and betamethasone dipropionate topical suspension contains calcipotriene and betamethasone dipropionate. It is for topical use only. Calcipotriene is a synthetic vitamin D 3analog. Calcipotriene. Calcipotriene is a vitamin D analog and has the chemical name (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.3, and the following structural formula (calcipotriene is a white to almost white, crystalline compound):. Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21- bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C 28H 37FO 7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder):. Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of calcipotriene and betamethasone dipropionate topical suspension contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, mineral oil and polyoxypropylene stearyl ether. Calcipotriene and betamethasone dipropionate topical suspension is an odorless clear to slightly off-white suspension."
},
{
"NDCCode": "0781-7165-35",
"PackageDescription": "1 TUBE in 1 CARTON (0781-7165-35) / 60 g in 1 TUBE",
"NDC11Code": "00781-7165-35",
"ProductNDC": "0781-7165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140331",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201615",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140331",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "Calcipotriene and betamethasone dipropionate ointment contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1(alpha),3(beta),24-triol, with the molecular formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of calcipotriene and betamethasone dipropionate ointment contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in off-white to yellow paraffin ointment base of caprylic/capric triglycerides, diazolidinyl urea, all-rac-alpha-tocopherol and white petrolatum."
},
{
"NDCCode": "33261-643-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-643-30)",
"NDC11Code": "33261-0643-30",
"ProductNDC": "33261-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078955",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.",
"Description": "hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. C16H21NO2.HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake."
},
{
"NDCCode": "42291-643-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42291-643-01)",
"NDC11Code": "42291-0643-01",
"ProductNDC": "42291-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 60",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140523",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "38; 9",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-03-27"
},
{
"NDCCode": "45802-816-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0816-96",
"ProductNDC": "45802-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene, Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200174",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE",
"StrengthNumber": "50; .643",
"StrengthUnit": "ug/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.",
"Description": "Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum."
},
{
"NDCCode": "45802-889-18",
"PackageDescription": "2 BOTTLE in 1 CARTON (45802-889-18) / 60 g in 1 BOTTLE",
"NDC11Code": "45802-0889-18",
"ProductNDC": "45802-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201009",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212367",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201009",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59922-643-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59922-643-60) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>59922-0643-60</NDC11Code>
<ProductNDC>59922-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vafseo</ProprietaryName>
<NonProprietaryName>Vadadustat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215192</ApplicationNumber>
<LabelerName>Akebia Therapeutics, Inc.</LabelerName>
<SubstanceName>VADADUSTAT</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC], Organic Anion Transporter 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use: 1 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being., 2 VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)].</IndicationAndUsage>
<Description>VAFSEO contains vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Vadadustat is 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid. Vadadustat has a molecular weight of 306.70. The empirical formula is C14H11ClN2O4. The chemical structure is. Vadadustat is a white to off-white solid that is practically insoluble in water. Vadadustat is formulated as a film-coated, immediate-release tablet for oral administration. VAFSEO is available in 150 mg, 300 mg and 450 mg strengths. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc. Colorants include:150 mg tablet - titanium dioxide300 mg tablet - titanium dioxide and yellow iron oxide450 mg tablet - titanium dioxide, iron oxide red and ferrosoferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>59922-641-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59922-641-60) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>59922-0641-60</NDC11Code>
<ProductNDC>59922-641</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vafseo</ProprietaryName>
<NonProprietaryName>Vadadustat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215192</ApplicationNumber>
<LabelerName>Akebia Therapeutics, Inc.</LabelerName>
<SubstanceName>VADADUSTAT</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC], Organic Anion Transporter 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use: 1 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being., 2 VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)].</IndicationAndUsage>
<Description>VAFSEO contains vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Vadadustat is 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid. Vadadustat has a molecular weight of 306.70. The empirical formula is C14H11ClN2O4. The chemical structure is. Vadadustat is a white to off-white solid that is practically insoluble in water. Vadadustat is formulated as a film-coated, immediate-release tablet for oral administration. VAFSEO is available in 150 mg, 300 mg and 450 mg strengths. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc. Colorants include:150 mg tablet - titanium dioxide300 mg tablet - titanium dioxide and yellow iron oxide450 mg tablet - titanium dioxide, iron oxide red and ferrosoferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>59922-642-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59922-642-60) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>59922-0642-60</NDC11Code>
<ProductNDC>59922-642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vafseo</ProprietaryName>
<NonProprietaryName>Vadadustat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215192</ApplicationNumber>
<LabelerName>Akebia Therapeutics, Inc.</LabelerName>
<SubstanceName>VADADUSTAT</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC], Organic Anion Transporter 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use: 1 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being., 2 VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)].</IndicationAndUsage>
<Description>VAFSEO contains vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Vadadustat is 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid. Vadadustat has a molecular weight of 306.70. The empirical formula is C14H11ClN2O4. The chemical structure is. Vadadustat is a white to off-white solid that is practically insoluble in water. Vadadustat is formulated as a film-coated, immediate-release tablet for oral administration. VAFSEO is available in 150 mg, 300 mg and 450 mg strengths. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc. Colorants include:150 mg tablet - titanium dioxide300 mg tablet - titanium dioxide and yellow iron oxide450 mg tablet - titanium dioxide, iron oxide red and ferrosoferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-643-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-643-60)</PackageDescription>
<NDC11Code>16590-0643-60</NDC11Code>
<ProductNDC>16590-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078881</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed.</Description>
</NDC>
<NDC>
<NDCCode>21695-643-60</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (21695-643-60)</PackageDescription>
<NDC11Code>21695-0643-60</NDC11Code>
<ProductNDC>21695-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065148</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC],Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>35356-643-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (35356-643-60)</PackageDescription>
<NDC11Code>35356-0643-60</NDC11Code>
<ProductNDC>35356-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090964</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>42549-643-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42549-643-60)</PackageDescription>
<NDC11Code>42549-0643-60</NDC11Code>
<ProductNDC>42549-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077712</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>43353-643-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43353-643-60)</PackageDescription>
<NDC11Code>43353-0643-60</NDC11Code>
<ProductNDC>43353-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075743</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>43598-643-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-643-60) </PackageDescription>
<NDC11Code>43598-0643-60</NDC11Code>
<ProductNDC>43598-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<ProprietaryNameSuffix>Sacubitril And Valsartan</ProprietaryNameSuffix>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213627</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>24; 26</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are calcium carbonate, crospovidone, magnesium stearate, microcrystalline cellulose, polysorbate 80 and silicon dioxide. The film-coating material contains, diacetylated monoglycerides, hypromellose. Imprinting ink contains, ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>45865-643-60</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-60) </PackageDescription>
<NDC11Code>45865-0643-60</NDC11Code>
<ProductNDC>45865-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110610</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49035-643-60</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (49035-643-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49035-0643-60</NDC11Code>
<ProductNDC>49035-643</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Allergy And Congestion Relief</ProprietaryName>
<NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076050</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<SubstanceName>LORATADINE; PSEUDOEPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>5; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itchy, watery eyes. runny nose. itching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51316-643-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (51316-643-04) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51316-0643-04</NDC11Code>
<ProductNDC>51316-643</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dye Free Infants Pain And Fever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Usestemporarily:. - reduces fever - relieves minor aches and pains due to: : 1 the common cold, 2 flu, 3 headache, 4 sore throat, 5 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-643-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (52959-643-60)</PackageDescription>
<NDC11Code>52959-0643-60</NDC11Code>
<ProductNDC>52959-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>58411-643-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-643-60) / 21 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0643-60</NDC11Code>
<ProductNDC>58411-643</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Radiant Foundation N</ProprietaryName>
<ProprietaryNameSuffix>O60</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.07; .3</StrengthNumber>
<StrengthUnit>g/21mL; g/21mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-643-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (63187-643-60) </PackageDescription>
<NDC11Code>63187-0643-60</NDC11Code>
<ProductNDC>63187-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200562</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: sodium lauryl sulfate, edible inks, gelatin, lactose monohydrate, crospovidone, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>66267-643-60</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOTTLE (66267-643-60) </PackageDescription>
<NDC11Code>66267-0643-60</NDC11Code>
<ProductNDC>66267-643</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pluspharma</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060327</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves bloating and pressure commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68001-643-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68001-643-06) </PackageDescription>
<NDC11Code>68001-0643-06</NDC11Code>
<ProductNDC>68001-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210203</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15H 22FN 3O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula:. Capecitabine USP is a white or almost white powder. Capecitabine USP is freely soluble in anhydrous ethanol, sparingly soluble in water and practically insoluble in heptane. Capecitabine tablets, USP are supplied as oval shaped film-coated tablets for oral use. Each light peach colored tablet contains 150 mg capecitabine, USP and each light peach colored tablet contains 500 mg capecitabine, USP. The inactive ingredients in capecitabine tablets include: croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The peach or light peach film coating contains hypromellose, iron oxide red, iron oxide yellow, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-643-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-643-60) </PackageDescription>
<NDC11Code>71205-0643-60</NDC11Code>
<ProductNDC>71205-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206948</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules, USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7.Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
</NDC>
<NDC>
<NDCCode>72189-643-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72189-643-60) </PackageDescription>
<NDC11Code>72189-0643-60</NDC11Code>
<ProductNDC>72189-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078329</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. [chem structure]. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-643-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76420-643-60) </PackageDescription>
<NDC11Code>76420-0643-60</NDC11Code>
<ProductNDC>76420-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210959</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the. Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1): Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
<Description>Hydroxychloroquine is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate USP is a white or off-white to slightly yellowish color powder, freely soluble in water and practically insoluble in ethanol. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: crospovidone, lactose monohydrate and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0168-0267-60</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (0168-0267-60) </PackageDescription>
<NDC11Code>00168-0267-60</NDC11Code>
<ProductNDC>0168-0267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>LOTION, AUGMENTED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077111</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betamethasone dipropionate lotion (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.</IndicationAndUsage>
<Description>Betamethasone Dipropionate Lotion USP (Augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. Each gram of betamethasone dipropionate lotion USP (augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion base of purified water, isopropyl alcohol (30%), phosphoric acid used to adjust the pH, hydroxypropyl cellulose, propylene glycol, and monobasic sodium phosphate (monohydrate).</Description>
</NDC>
<NDC>
<NDCCode>0430-3230-15</NDCCode>
<PackageDescription>100 CARTON in 1 CASE (0430-3230-15) > 1 TUBE in 1 CARTON > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00430-3230-15</NDC11Code>
<ProductNDC>0430-3230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021852</ApplicationNumber>
<LabelerName>Warner Chilcott (US), LLC</LabelerName>
<SubstanceName>CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .643</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0430-3240-15</NDCCode>
<PackageDescription>30 CARTON in 1 CASE (0430-3240-15) > 1 BOTTLE in 1 CARTON > 60 g in 1 BOTTLE</PackageDescription>
<NDC11Code>00430-3240-15</NDC11Code>
<ProductNDC>0430-3240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taclonex Scalp</ProprietaryName>
<NonProprietaryName>Calcipotriene 0.005% And Betamethasone Dipropionate 0.064%</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022185</ApplicationNumber>
<LabelerName>Warner Chilcott (US), LLC</LabelerName>
<SubstanceName>CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .643</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0713-0848-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLE</PackageDescription>
<NDC11Code>00713-0848-60</NDC11Code>
<ProductNDC>0713-0848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210765</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Calcipotriene and betamethasone dipropionate topical suspension contains calcipotriene and betamethasone dipropionate. It is for topical use only. Calcipotriene is a synthetic vitamin D 3analog. Calcipotriene. Calcipotriene is a vitamin D analog and has the chemical name (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.3, and the following structural formula (calcipotriene is a white to almost white, crystalline compound):. Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21- bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C 28H 37FO 7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder):. Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of calcipotriene and betamethasone dipropionate topical suspension contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, mineral oil and polyoxypropylene stearyl ether. Calcipotriene and betamethasone dipropionate topical suspension is an odorless clear to slightly off-white suspension.</Description>
</NDC>
<NDC>
<NDCCode>0713-0848-92</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (0713-0848-92) / 60 g in 1 BOTTLE</PackageDescription>
<NDC11Code>00713-0848-92</NDC11Code>
<ProductNDC>0713-0848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210765</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Calcipotriene and betamethasone dipropionate topical suspension contains calcipotriene and betamethasone dipropionate. It is for topical use only. Calcipotriene is a synthetic vitamin D 3analog. Calcipotriene. Calcipotriene is a vitamin D analog and has the chemical name (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol, with the empirical formula C 27H 40O 3, a molecular weight of 412.3, and the following structural formula (calcipotriene is a white to almost white, crystalline compound):. Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21- bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C 28H 37FO 7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder):. Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of calcipotriene and betamethasone dipropionate topical suspension contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, mineral oil and polyoxypropylene stearyl ether. Calcipotriene and betamethasone dipropionate topical suspension is an odorless clear to slightly off-white suspension.</Description>
</NDC>
<NDC>
<NDCCode>0781-7165-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0781-7165-35) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00781-7165-35</NDC11Code>
<ProductNDC>0781-7165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140331</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201615</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140331</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>Calcipotriene and betamethasone dipropionate ointment contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1(alpha),3(beta),24-triol, with the molecular formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of calcipotriene and betamethasone dipropionate ointment contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in off-white to yellow paraffin ointment base of caprylic/capric triglycerides, diazolidinyl urea, all-rac-alpha-tocopherol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>33261-643-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-643-30)</PackageDescription>
<NDC11Code>33261-0643-30</NDC11Code>
<ProductNDC>33261-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078955</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. C16H21NO2.HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake.</Description>
</NDC>
<NDC>
<NDCCode>42291-643-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42291-643-01)</PackageDescription>
<NDC11Code>42291-0643-01</NDC11Code>
<ProductNDC>42291-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 60</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>38; 9</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-816-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0816-96</NDC11Code>
<ProductNDC>45802-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene, Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200174</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>50; .643</StrengthNumber>
<StrengthUnit>ug/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula. Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-889-18</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (45802-889-18) / 60 g in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0889-18</NDC11Code>
<ProductNDC>45802-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201009</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212367</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201009</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension.</Description>
</NDC>
</NDCList>