{
"NDC": [
{
"NDCCode": "10596-712-60",
"PackageDescription": "1 TUBE in 1 BOX (10596-712-60) > 177 mL in 1 TUBE",
"NDC11Code": "10596-0712-60",
"ProductNDC": "10596-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jergens",
"ProprietaryNameSuffix": "Bb Body",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150109",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "OCTISALATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "8.8; 2.2; 1.9",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "10596-709-60",
"PackageDescription": "1 TUBE in 1 BOX (10596-709-60) > 177 mL in 1 TUBE",
"NDC11Code": "10596-0709-60",
"ProductNDC": "10596-709",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jergens Natural Glow",
"ProprietaryNameSuffix": "Daily Moisturizer With Sunscreen Spf 20",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150406",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "2.2; 1.9; 8.8",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "10596-710-60",
"PackageDescription": "1 TUBE in 1 BOX (10596-710-60) > 177 mL in 1 TUBE",
"NDC11Code": "10596-0710-60",
"ProductNDC": "10596-710",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jergens Natural Glow",
"ProprietaryNameSuffix": "Daily Moisturizer With Sunscreen Spf 20",
"NonProprietaryName": "Avobenzone,octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150409",
"EndMarketingDate": "20181231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2.2; 8.8; 1.9",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150409",
"EndMarketingDatePackage": "20181231",
"SamplePackage": "N"
},
{
"NDCCode": "10596-711-60",
"PackageDescription": "1 TUBE in 1 BOX (10596-711-60) > 177 mL in 1 TUBE",
"NDC11Code": "10596-0711-60",
"ProductNDC": "10596-711",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jergens",
"ProprietaryNameSuffix": "Bb Body",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150118",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "OCTISALATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "8.8; 2.2; 1.9",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "35356-712-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-712-60)",
"NDC11Code": "35356-0712-60",
"ProductNDC": "35356-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43063-712-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (43063-712-60) ",
"NDC11Code": "43063-0712-60",
"ProductNDC": "43063-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180824",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "43068-712-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (43068-712-02) ",
"NDC11Code": "43068-0712-02",
"ProductNDC": "43068-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bysanti",
"NonProprietaryName": "Milsaperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220358",
"LabelerName": "Vanda Pharmaceuticals Inc.",
"SubstanceName": "MILSAPERIDONE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "BYSANTI is indicated for the: 1 Treatment of schizophrenia in adults [see Clinical Studies (14.1)]., 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2)].",
"Description": "The active ingredient in BYSANTI is milsaperidone, an atypical antipsychotic that is in the piperidinyl-benzisoxazole derivative chemical class. Its chemical name is benzenemethanol, 4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxy-α- methyl-, (αS)-. Its molecular formula is C24H29FN2O4 and its molecular weight is 428.50. Milsaperidone is a white to off-white finely crystalline powder. The structural formula of milsaperidone is. Milsaperidone is a white to off-white finely crystalline powder. BYSANTI (milsaperidone) tablets are for oral administration only. Coated tablets contain 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of milsaperidone. Inactive ingredients are the following: colloidal silicon dioxide, crospovidone, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and water (removed during processing)."
},
{
"NDCCode": "43744-712-60",
"PackageDescription": "750 g in 1 DRUM (43744-712-60)",
"NDC11Code": "43744-0712-60",
"ProductNDC": "43744-712",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Penicillamine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130404",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "PENICILLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "46122-712-60",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-712-60) / 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "46122-0712-60",
"ProductNDC": "46122-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Sinus Severe Congestion And Pain",
"NonProprietaryName": "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220501",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: nasal congestionheadacheminor aches and painssinus congestion and pressure. promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "47335-712-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (47335-712-86) ",
"NDC11Code": "47335-0712-86",
"ProductNDC": "47335-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141215",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round 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 C 12H 21NO 8S 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, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "51326-712-60",
"PackageDescription": "60 CLOTH in 1 JAR (51326-712-60) ",
"NDC11Code": "51326-0712-60",
"ProductNDC": "51326-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gly-sal 10-2",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190528",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Topiderm, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190528",
"SamplePackage": "N",
"IndicationAndUsage": "Cleansing pads for the treatment of acne, with the skin enhancement properties of Glycolic acid."
},
{
"NDCCode": "52747-712-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (52747-712-60) ",
"NDC11Code": "52747-0712-60",
"ProductNDC": "52747-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Integra Plus",
"NonProprietaryName": "Ferrous Fumarate And Polysacchride Iron Vitamin Mineral Complex Supplement",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090427",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "U.S. Pharmaceutical Corporation",
"SubstanceName": "FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ASCORBIC ACID; NIACIN; THIAMINE MONONITRATE; RIBOFLAVIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN",
"StrengthNumber": "62.5; 62.5; 1; 210; 20; 5; 5; 5; 25; 300",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090427",
"SamplePackage": "N",
"Description": "DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) ......191.1 mg Polysaccharide Iron Complex... 135.9 mg (Equivalent to about 125 mg of elemental iron) Vitamin C (from ProAscorb C‡)....210 mg Folic Acid .....1 mg Thiamine Mononitrate (B1)...5 mg Riboflavin (B2)....5 mg Niacin (B3) . 20 mg d-Calcium Pantothenate (B5)..7 mg Pyridoxine HCl (B6) ...25 mg Biotin (B7)......300 mcg Cyanocobalamin (B12) .. 10 mcg."
},
{
"NDCCode": "60760-712-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-712-60) ",
"NDC11Code": "60760-0712-60",
"ProductNDC": "60760-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202882",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200304",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole Sodium Delayed-Release Tablets are indicated for:.",
"Description": "The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4-dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S . 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2."
},
{
"NDCCode": "62756-712-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62756-712-86) ",
"NDC11Code": "62756-0712-86",
"ProductNDC": "62756-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2018-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090327",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round 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, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "63187-712-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (63187-712-60) ",
"NDC11Code": "63187-0712-60",
"ProductNDC": "63187-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205115",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2019-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160601",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms:. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Calymmatobacterium granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
"Description": "Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8 H2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. USP Dissolution Test pending."
},
{
"NDCCode": "63402-712-01",
"PackageDescription": "1 INHALER in 1 CARTON (63402-712-01) > 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "63402-0712-01",
"ProductNDC": "63402-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvesco",
"NonProprietaryName": "Ciclesonide",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20191201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021658",
"LabelerName": "Sunovion Pharmaceuticals Inc.",
"SubstanceName": "CICLESONIDE",
"StrengthNumber": "160",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081001",
"EndMarketingDatePackage": "20191201",
"SamplePackage": "N"
},
{
"NDCCode": "63402-712-02",
"PackageDescription": "1 INHALER in 1 CARTON (63402-712-02) > 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "63402-0712-02",
"ProductNDC": "63402-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvesco",
"NonProprietaryName": "Ciclesonide",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20191201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021658",
"LabelerName": "Sunovion Pharmaceuticals Inc.",
"SubstanceName": "CICLESONIDE",
"StrengthNumber": "160",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081001",
"EndMarketingDatePackage": "20191201",
"SamplePackage": "N"
},
{
"NDCCode": "65862-712-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (65862-712-60) ",
"NDC11Code": "65862-0712-60",
"ProductNDC": "65862-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atazanavir Sulfate",
"NonProprietaryName": "Atazanavir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204806",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180625",
"SamplePackage": "N",
"IndicationAndUsage": "Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use.",
"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. Atazanavir capsules are available for oral administration in strengths of 100 mg, 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 113.903 mg, 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C blue 2, gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and titanium dioxide."
},
{
"NDCCode": "70515-712-01",
"PackageDescription": "1 INHALER in 1 CARTON (70515-712-01) / 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "70515-0712-01",
"ProductNDC": "70515-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvesco",
"NonProprietaryName": "Ciclesonide",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021658",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "CICLESONIDE",
"StrengthNumber": "160",
"StrengthUnit": "ug/1",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use:. ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age.",
"Description": "The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α). The empirical formula is C 32H 44O 7and its molecular weight is 540.7. Its structural formula is as follows:. Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform. ALVESCO 80 mcg and ALVESCO 160 mcg are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO."
},
{
"NDCCode": "70515-712-02",
"PackageDescription": "1 INHALER in 1 CARTON (70515-712-02) / 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "70515-0712-02",
"ProductNDC": "70515-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvesco",
"NonProprietaryName": "Ciclesonide",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021658",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "CICLESONIDE",
"StrengthNumber": "160",
"StrengthUnit": "ug/1",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "Y",
"IndicationAndUsage": "ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use:. ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age.",
"Description": "The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α). The empirical formula is C 32H 44O 7and its molecular weight is 540.7. Its structural formula is as follows:. Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform. ALVESCO 80 mcg and ALVESCO 160 mcg are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO."
},
{
"NDCCode": "70515-712-05",
"PackageDescription": "1 INHALER in 1 CARTON (70515-712-05) / 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "70515-0712-05",
"ProductNDC": "70515-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alvesco",
"NonProprietaryName": "Ciclesonide",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021658",
"LabelerName": "Covis Pharma US, Inc",
"SubstanceName": "CICLESONIDE",
"StrengthNumber": "160",
"StrengthUnit": "ug/1",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210430",
"SamplePackage": "N",
"IndicationAndUsage": "ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use:. ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age.",
"Description": "The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α). The empirical formula is C 32H 44O 7and its molecular weight is 540.7. Its structural formula is as follows:. Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform. ALVESCO 80 mcg and ALVESCO 160 mcg are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO."
},
{
"NDCCode": "71205-712-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-712-60) ",
"NDC11Code": "71205-0712-60",
"ProductNDC": "71205-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065063",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)."
},
{
"NDCCode": "76420-712-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76420-712-60) ",
"NDC11Code": "76420-0712-60",
"ProductNDC": "76420-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215630",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "44118-712-08",
"PackageDescription": "237 mL in 1 BOTTLE (44118-712-08) ",
"NDC11Code": "44118-0712-08",
"ProductNDC": "44118-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plexion Ns",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211006",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Eckson Labs, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "98",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2022-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211006",
"SamplePackage": "N",
"IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).",
"Description": "Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "49281-712-40",
"PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-712-40) > .1 mL in 1 SYRINGE, GLASS (49281-712-48)",
"NDC11Code": "49281-0712-40",
"ProductNDC": "49281-712",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Intradermal Quadrivalent",
"NonProprietaryName": "Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20170701",
"EndMarketingDate": "20180630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "9; 9; 9; 9",
"StrengthUnit": "ug/.1mL; ug/.1mL; ug/.1mL; ug/.1mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
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},
{
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"LabelerName": "Gensavis Pharmaceuticals, LLC",
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},
{
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"ProprietaryName": "Dihydrocodeine Bitartrate, Acetaminophen And Caffeine",
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"IndicationAndUsage": "Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are supplied in tablet form for oral administration. Each tablet contains:Acetaminophenִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ712.8 mgCaffeineִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ60 mgDihydrocodeine* bitartrateִִִִִִִִִִִִִִִִִִִִִִ32 mg*Warning: May be habit forming. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder, is a central nervous system stimulant. It has the following structural formula. Dihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmorphinan-6a-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula. In addition, each tablet also contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
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"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Extended-Release Tabletscontain 0.375 mg of hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Extended-Release Tabletsalso contain as inactive ingredients: microcrystalline cellulose, Hydroxypropyl cellulose, colloidal silicon dioxide, and magnesium stearate."
},
{
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"IndicationAndUsage": "Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Tablets, USP are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose."
},
{
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"SubstanceName": "HYOSCYAMINE SULFATE",
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"IndicationAndUsage": "Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Tablets, USP are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose."
}
]
}
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<Description>The active ingredient in BYSANTI is milsaperidone, an atypical antipsychotic that is in the piperidinyl-benzisoxazole derivative chemical class. Its chemical name is benzenemethanol, 4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxy-α- methyl-, (αS)-. Its molecular formula is C24H29FN2O4 and its molecular weight is 428.50. Milsaperidone is a white to off-white finely crystalline powder. The structural formula of milsaperidone is. Milsaperidone is a white to off-white finely crystalline powder. BYSANTI (milsaperidone) tablets are for oral administration only. Coated tablets contain 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of milsaperidone. Inactive ingredients are the following: colloidal silicon dioxide, crospovidone, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and water (removed during processing).</Description>
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<ProprietaryName>Mucus Relief Sinus Severe Congestion And Pain</ProprietaryName>
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<StartMarketingDatePackage>20220501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: nasal congestionheadacheminor aches and painssinus congestion and pressure. promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47335-712-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (47335-712-86) </PackageDescription>
<NDC11Code>47335-0712-86</NDC11Code>
<ProductNDC>47335-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round 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 C 12H 21NO 8S 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, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>51326-712-60</NDCCode>
<PackageDescription>60 CLOTH in 1 JAR (51326-712-60) </PackageDescription>
<NDC11Code>51326-0712-60</NDC11Code>
<ProductNDC>51326-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gly-sal 10-2</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190528</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Topiderm, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cleansing pads for the treatment of acne, with the skin enhancement properties of Glycolic acid.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52747-712-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (52747-712-60) </PackageDescription>
<NDC11Code>52747-0712-60</NDC11Code>
<ProductNDC>52747-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Integra Plus</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate And Polysacchride Iron Vitamin Mineral Complex Supplement</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090427</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>U.S. Pharmaceutical Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ASCORBIC ACID; NIACIN; THIAMINE MONONITRATE; RIBOFLAVIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN</SubstanceName>
<StrengthNumber>62.5; 62.5; 1; 210; 20; 5; 5; 5; 25; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) ......191.1 mg Polysaccharide Iron Complex... 135.9 mg (Equivalent to about 125 mg of elemental iron) Vitamin C (from ProAscorb C‡)....210 mg Folic Acid .....1 mg Thiamine Mononitrate (B1)...5 mg Riboflavin (B2)....5 mg Niacin (B3) . 20 mg d-Calcium Pantothenate (B5)..7 mg Pyridoxine HCl (B6) ...25 mg Biotin (B7)......300 mcg Cyanocobalamin (B12) .. 10 mcg.</Description>
</NDC>
<NDC>
<NDCCode>60760-712-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-712-60) </PackageDescription>
<NDC11Code>60760-0712-60</NDC11Code>
<ProductNDC>60760-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202882</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole Sodium Delayed-Release Tablets are indicated for:.</IndicationAndUsage>
<Description>The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4-dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S . 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>62756-712-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62756-712-86) </PackageDescription>
<NDC11Code>62756-0712-86</NDC11Code>
<ProductNDC>62756-712</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>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round 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, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>63187-712-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (63187-712-60) </PackageDescription>
<NDC11Code>63187-0712-60</NDC11Code>
<ProductNDC>63187-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205115</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms:. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Calymmatobacterium granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
<Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8 H2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>63402-712-01</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (63402-712-01) > 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>63402-0712-01</NDC11Code>
<ProductNDC>63402-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvesco</ProprietaryName>
<NonProprietaryName>Ciclesonide</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20191201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021658</ApplicationNumber>
<LabelerName>Sunovion Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLESONIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081001</StartMarketingDatePackage>
<EndMarketingDatePackage>20191201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63402-712-02</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (63402-712-02) > 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>63402-0712-02</NDC11Code>
<ProductNDC>63402-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvesco</ProprietaryName>
<NonProprietaryName>Ciclesonide</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20191201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021658</ApplicationNumber>
<LabelerName>Sunovion Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLESONIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081001</StartMarketingDatePackage>
<EndMarketingDatePackage>20191201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-712-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (65862-712-60) </PackageDescription>
<NDC11Code>65862-0712-60</NDC11Code>
<ProductNDC>65862-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atazanavir Sulfate</ProprietaryName>
<NonProprietaryName>Atazanavir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204806</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use.</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. Atazanavir capsules are available for oral administration in strengths of 100 mg, 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 113.903 mg, 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C blue 2, gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70515-712-01</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (70515-712-01) / 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0712-01</NDC11Code>
<ProductNDC>70515-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvesco</ProprietaryName>
<NonProprietaryName>Ciclesonide</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20180326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021658</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>CICLESONIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use:. ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age.</IndicationAndUsage>
<Description>The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α). The empirical formula is C 32H 44O 7and its molecular weight is 540.7. Its structural formula is as follows:. Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform. ALVESCO 80 mcg and ALVESCO 160 mcg are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO.</Description>
</NDC>
<NDC>
<NDCCode>70515-712-02</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (70515-712-02) / 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0712-02</NDC11Code>
<ProductNDC>70515-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvesco</ProprietaryName>
<NonProprietaryName>Ciclesonide</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20180326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021658</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>CICLESONIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use:. ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age.</IndicationAndUsage>
<Description>The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α). The empirical formula is C 32H 44O 7and its molecular weight is 540.7. Its structural formula is as follows:. Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform. ALVESCO 80 mcg and ALVESCO 160 mcg are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO.</Description>
</NDC>
<NDC>
<NDCCode>70515-712-05</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (70515-712-05) / 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>70515-0712-05</NDC11Code>
<ProductNDC>70515-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alvesco</ProprietaryName>
<NonProprietaryName>Ciclesonide</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20180326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021658</ApplicationNumber>
<LabelerName>Covis Pharma US, Inc</LabelerName>
<SubstanceName>CICLESONIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use:. ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age.</IndicationAndUsage>
<Description>The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α). The empirical formula is C 32H 44O 7and its molecular weight is 540.7. Its structural formula is as follows:. Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform. ALVESCO 80 mcg and ALVESCO 160 mcg are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO.</Description>
</NDC>
<NDC>
<NDCCode>71205-712-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-712-60) </PackageDescription>
<NDC11Code>71205-0712-60</NDC11Code>
<ProductNDC>71205-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065063</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).</Description>
</NDC>
<NDC>
<NDCCode>76420-712-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76420-712-60) </PackageDescription>
<NDC11Code>76420-0712-60</NDC11Code>
<ProductNDC>76420-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215630</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is. N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>44118-712-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (44118-712-08) </PackageDescription>
<NDC11Code>44118-0712-08</NDC11Code>
<ProductNDC>44118-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plexion Ns</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211006</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Eckson Labs, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>98</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).</IndicationAndUsage>
<Description>Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>49281-712-40</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-712-40) > .1 mL in 1 SYRINGE, GLASS (49281-712-48)</PackageDescription>
<NDC11Code>49281-0712-40</NDC11Code>
<ProductNDC>49281-712</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Intradermal Quadrivalent</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20170701</StartMarketingDate>
<EndMarketingDate>20180630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>9; 9; 9; 9</StrengthNumber>
<StrengthUnit>ug/.1mL; ug/.1mL; ug/.1mL; ug/.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>52304-712-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (52304-712-04)</PackageDescription>
<NDC11Code>52304-0712-04</NDC11Code>
<ProductNDC>52304-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novaferrum</ProprietaryName>
<NonProprietaryName>Polysacchride Iron Vitamin Mineral Complex</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100415</StartMarketingDate>
<EndMarketingDate>20141215</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Gensavis Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; FOLIC ACID; IRON</SubstanceName>
<StrengthNumber>60; 1; 100</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-12-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>54868-5900-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (54868-5900-0)</PackageDescription>
<NDC11Code>54868-5900-00</NDC11Code>
<ProductNDC>54868-5900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dihydrocodeine Bitartrate, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Dihydrocodeine Bitartrate, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040701</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>DIHYDROCODEINE BITARTRATE; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>32; 712.8; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are supplied in tablet form for oral administration. Each tablet contains:Acetaminophenִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ712.8 mgCaffeineִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ60 mgDihydrocodeine* bitartrateִִִִִִִִִִִִִִִִִִִִִִ32 mg*Warning: May be habit forming. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder, is a central nervous system stimulant. It has the following structural formula. Dihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmorphinan-6a-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula. In addition, each tablet also contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62135-860-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-860-60) </PackageDescription>
<NDC11Code>62135-0860-60</NDC11Code>
<ProductNDC>62135-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240605</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Extended-Release Tabletscontain 0.375 mg of hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Extended-Release Tabletsalso contain as inactive ingredients: microcrystalline cellulose, Hydroxypropyl cellulose, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>63187-411-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (63187-411-60) </PackageDescription>
<NDC11Code>63187-0411-60</NDC11Code>
<ProductNDC>63187-411</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Tablets, USP are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>71205-698-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-698-60) </PackageDescription>
<NDC11Code>71205-0698-60</NDC11Code>
<ProductNDC>71205-698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Tablets, USP are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
</NDCList>