{
"NDC": [
{
"NDCCode": "45802-889-18",
"PackageDescription": "2 BOTTLE in 1 CARTON (45802-889-18) / 60 g in 1 BOTTLE",
"NDC11Code": "45802-0889-18",
"ProductNDC": "45802-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201009",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212367",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201009",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension."
},
{
"NDCCode": "23155-889-18",
"PackageDescription": "40000 TABLET, FILM COATED in 1 CONTAINER (23155-889-18) ",
"NDC11Code": "23155-0889-18",
"ProductNDC": "23155-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurasidone Hydrochloride",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208058",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
"Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch and titanium dioxide."
},
{
"NDCCode": "45802-889-96",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-889-96) / 60 g in 1 BOTTLE",
"NDC11Code": "45802-0889-96",
"ProductNDC": "45802-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"NonProprietaryName": "Calcipotriene And Betamethasone Dipropionate",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201009",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212367",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE",
"StrengthNumber": ".5; 50",
"StrengthUnit": "mg/g; ug/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201009",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension."
},
{
"NDCCode": "45802-138-18",
"PackageDescription": "1 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE",
"NDC11Code": "45802-0138-18",
"ProductNDC": "45802-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox Olamine",
"NonProprietaryName": "Ciclopirox Olamine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077364",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CICLOPIROX OLAMINE",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061214",
"SamplePackage": "N",
"IndicationAndUsage": "Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.",
"Description": "Ciclopirox Olamine Cream USP, 1.0% is for topical use. Each gram of ciclopirox olamine cream contains 10 mg of ciclopirox olamine equivalent to 7.70 mg of ciclopirox in a water miscible vanishing cream base consisting of benzyl alcohol NF, cetyl alcohol NF, lactic acid USP, light mineral oil NF, myristyl alcohol NF, octyldodecanol NF, polysorbate 60 NF, purified water USP, sorbitan monostearate NF, and stearyl alcohol NF. Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is. Ciclopirox olamine cream has a pH of 7."
},
{
"NDCCode": "45802-230-68",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (45802-230-68) > 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "45802-0230-68",
"ProductNDC": "45802-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hydrochloride Extended Release",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160129",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "45802-230-89",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (45802-230-89) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "45802-0230-89",
"ProductNDC": "45802-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hydrochloride Extended Release",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160129",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "16590-889-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-889-30)",
"NDC11Code": "16590-0889-30",
"ProductNDC": "16590-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022304",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1).",
"Description": "NUCYNTA® (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring."
},
{
"NDCCode": "16590-889-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16590-889-60)",
"NDC11Code": "16590-0889-60",
"ProductNDC": "16590-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022304",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1).",
"Description": "NUCYNTA® (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring."
},
{
"NDCCode": "16590-889-72",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (16590-889-72)",
"NDC11Code": "16590-0889-72",
"ProductNDC": "16590-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022304",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1).",
"Description": "NUCYNTA® (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring."
},
{
"NDCCode": "24236-889-24",
"PackageDescription": "200 TABLET, FILM COATED in 1 CANISTER (24236-889-24)",
"NDC11Code": "24236-0889-24",
"ProductNDC": "24236-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089686",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "42291-889-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42291-889-30)",
"NDC11Code": "42291-0889-30",
"ProductNDC": "42291-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077655",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "63187-889-28",
"PackageDescription": "1 BLISTER PACK in 1 POUCH (63187-889-28) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "63187-0889-28",
"ProductNDC": "63187-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aviane",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20010402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075796",
"LabelerName": "Proficient Rx LP",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N",
"IndicationAndUsage": "Aviane (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with Aviane (levonorgestrel and ethinyl estradiol tablets USP), 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α -pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. 7 light-green, inert tablets each containing: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Levonorgestrel, USP. Ethinyl Estradiol, USP."
},
{
"NDCCode": "65015-889-61",
"PackageDescription": "100 kg in 1 DRUM (65015-889-61) ",
"NDC11Code": "65015-0889-61",
"ProductNDC": "65015-889",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mafenide Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20181112",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mylan Laboratories Limited",
"SubstanceName": "MAFENIDE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "12-NOV-18"
},
{
"NDCCode": "66051-210-50",
"PackageDescription": "4 BOTTLE, PLASTIC in 1 BOX (66051-210-50) > 148 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "66051-0210-50",
"ProductNDC": "66051-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Haws Eyewash Additive",
"NonProprietaryName": "Purified Water",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL",
"StartMarketingDate": "20140703",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Haws Corporation",
"SubstanceName": "WATER",
"StrengthNumber": "889.6",
"StrengthUnit": "g/1000mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140703",
"SamplePackage": "N",
"IndicationAndUsage": "To preserve potable water in 5-20 gallons (18.93L-75.7L) self-contained emergency eyewash stations."
},
{
"NDCCode": "67457-889-10",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-889-10) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "67457-0889-10",
"ProductNDC": "67457-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosaprepitant",
"NonProprietaryName": "Fosaprepitant",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204015",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "FOSAPREPITANT DIMEGLUMINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190905",
"SamplePackage": "N",
"IndicationAndUsage": "Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. , 2 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). .",
"Description": "Fosaprepitant for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phosphonate (2:1) (salt). Its empirical formula is C23H22F7N4O6P⋅2(C7H17NO5) and its structural formula is. Fosaprepitant dimeglumine is a white to off-white amorphous powder with a molecular weight of 1004.83. It is freely soluble in methanol and water, insoluble in acetone and ethanol. Each vial of fosaprepitant for injection for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (18.8 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment)."
},
{
"NDCCode": "45802-009-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE",
"NDC11Code": "45802-0009-10",
"ProductNDC": "45802-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202849",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171004",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide oil ear drops is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.",
"Description": "Fluocinolone Acetonide Oil, 0.01% Ear Drops contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16, 17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil ear drops contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide oil ear drops is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide oil ear drops is heated just below 232°C (450°F) for at least 15 minutes."
},
{
"NDCCode": "45802-078-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMP",
"NDC11Code": "45802-0078-30",
"ProductNDC": "45802-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine",
"NonProprietaryName": "Brimonidine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209158",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "BRIMONIDINE TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230101",
"SamplePackage": "N",
"IndicationAndUsage": "Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.",
"Description": "Brimonidine Topical Gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C11H10BrN5 C4H6O6. It has the following structural formula. Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of Brimonidine Topical Gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients benzalkonium chloride, carbomer homopolymer type B, glycerin, propylene glycol, purified water, sodium hydroxide, and talc."
},
{
"NDCCode": "45802-170-03",
"PackageDescription": "1 TUBE in 1 CARTON (45802-170-03) > 28.35 g in 1 TUBE",
"NDC11Code": "45802-0170-03",
"ProductNDC": "45802-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100817",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "UREA",
"StrengthNumber": "400",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-170-53",
"PackageDescription": "1 TUBE in 1 CARTON (45802-170-53) > 85 g in 1 TUBE",
"NDC11Code": "45802-0170-53",
"ProductNDC": "45802-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100817",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "UREA",
"StrengthNumber": "400",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-170-77",
"PackageDescription": "1 TUBE in 1 CARTON (45802-170-77) > 198.6 g in 1 TUBE",
"NDC11Code": "45802-0170-77",
"ProductNDC": "45802-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100817",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "UREA",
"StrengthNumber": "400",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-263-37",
"PackageDescription": "60 APPLICATOR in 1 JAR (45802-263-37) / 1 mL in 1 APPLICATOR",
"NDC11Code": "45802-0263-37",
"ProductNDC": "45802-263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065049",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060531",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin Phosphate Topical Solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
"Description": "Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "45802-263-93",
"PackageDescription": "69 APPLICATOR in 1 JAR (45802-263-93) > 1 mL in 1 APPLICATOR",
"NDC11Code": "45802-0263-93",
"ProductNDC": "45802-263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065049",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-303-21",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (45802-303-21) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "45802-0303-21",
"ProductNDC": "45802-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088832",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-303-67",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (45802-303-67) > 24 TABLET in 1 BLISTER PACK",
"NDC11Code": "45802-0303-67",
"ProductNDC": "45802-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088832",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "45802-390-00",
"PackageDescription": "1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE",
"NDC11Code": "45802-0390-00",
"ProductNDC": "45802-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141120",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "45802-390-01",
"PackageDescription": "1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE",
"NDC11Code": "45802-0390-01",
"ProductNDC": "45802-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141120",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "45802-390-02",
"PackageDescription": "1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE",
"NDC11Code": "45802-0390-02",
"ProductNDC": "45802-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141120",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "45802-423-35",
"PackageDescription": "1 TUBE in 1 CARTON (45802-423-35) / 15 g in 1 TUBE",
"NDC11Code": "45802-0423-35",
"ProductNDC": "45802-423",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desonide",
"NonProprietaryName": "Desonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060822",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017426",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060822",
"SamplePackage": "N",
"IndicationAndUsage": "Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.",
"Description": "Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to off-white powder. The solubility of desonide in distilled water saturated with ether is 184 mg/L. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum."
},
{
"NDCCode": "45802-423-37",
"PackageDescription": "1 TUBE in 1 CARTON (45802-423-37) / 60 g in 1 TUBE",
"NDC11Code": "45802-0423-37",
"ProductNDC": "45802-423",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desonide",
"NonProprietaryName": "Desonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060822",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017426",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060918",
"SamplePackage": "N",
"IndicationAndUsage": "Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.",
"Description": "Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to off-white powder. The solubility of desonide in distilled water saturated with ether is 184 mg/L. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum."
},
{
"NDCCode": "45802-436-01",
"PackageDescription": "1 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBE",
"NDC11Code": "45802-0436-01",
"ProductNDC": "45802-436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tazarotene",
"NonProprietaryName": "Tazarotene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213079",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TAZAROTENE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230605",
"SamplePackage": "N",
"IndicationAndUsage": "Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).",
"Description": "Tazarotene Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of Tazarotene Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel contains the following inactive ingredients. benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine."
}
]
}
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<NDCList>
<NDC>
<NDCCode>45802-889-18</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (45802-889-18) / 60 g in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0889-18</NDC11Code>
<ProductNDC>45802-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201009</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212367</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201009</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension.</Description>
</NDC>
<NDC>
<NDCCode>23155-889-18</NDCCode>
<PackageDescription>40000 TABLET, FILM COATED in 1 CONTAINER (23155-889-18) </PackageDescription>
<NDC11Code>23155-0889-18</NDC11Code>
<ProductNDC>23155-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208058</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch and titanium dioxide.</Description>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (45802-889-96) / 60 g in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0889-96</NDC11Code>
<ProductNDC>45802-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene And Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Calcipotriene And Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201009</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212367</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE</SubstanceName>
<StrengthNumber>.5; 50</StrengthNumber>
<StrengthUnit>mg/g; ug/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201009</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Calcipotriene and Betamethasone Dipropionate Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D3 analog. Calcipotriene Hydrate. Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22- tetraene-1,3,24-triol,24-cyclopropyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound). Betamethasone Dipropionate. Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11ß,16ß), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder). Calcipotriene and Betamethasone Dipropionate Topical Suspension. Each gram of Calcipotriene and Betamethasone Dipropionate Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil. Calcipotriene and Betamethasone Dipropionate Topical Suspension is an odorless, clear to slightly off-white suspension.</Description>
</NDC>
<NDC>
<NDCCode>45802-138-18</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0138-18</NDC11Code>
<ProductNDC>45802-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox Olamine</ProprietaryName>
<NonProprietaryName>Ciclopirox Olamine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077364</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CICLOPIROX OLAMINE</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.</IndicationAndUsage>
<Description>Ciclopirox Olamine Cream USP, 1.0% is for topical use. Each gram of ciclopirox olamine cream contains 10 mg of ciclopirox olamine equivalent to 7.70 mg of ciclopirox in a water miscible vanishing cream base consisting of benzyl alcohol NF, cetyl alcohol NF, lactic acid USP, light mineral oil NF, myristyl alcohol NF, octyldodecanol NF, polysorbate 60 NF, purified water USP, sorbitan monostearate NF, and stearyl alcohol NF. Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is. Ciclopirox olamine cream has a pH of 7.</Description>
</NDC>
<NDC>
<NDCCode>45802-230-68</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (45802-230-68) > 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0230-68</NDC11Code>
<ProductNDC>45802-230</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin And Pseudoephedrine Hydrochloride Extended Release</ProprietaryName>
<NonProprietaryName>Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091071</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45802-230-89</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (45802-230-89) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0230-89</NDC11Code>
<ProductNDC>45802-230</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin And Pseudoephedrine Hydrochloride Extended Release</ProprietaryName>
<NonProprietaryName>Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091071</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-889-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16590-889-30)</PackageDescription>
<NDC11Code>16590-0889-30</NDC11Code>
<ProductNDC>16590-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1).</IndicationAndUsage>
<Description>NUCYNTA® (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring.</Description>
</NDC>
<NDC>
<NDCCode>16590-889-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16590-889-60)</PackageDescription>
<NDC11Code>16590-0889-60</NDC11Code>
<ProductNDC>16590-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1).</IndicationAndUsage>
<Description>NUCYNTA® (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring.</Description>
</NDC>
<NDC>
<NDCCode>16590-889-72</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (16590-889-72)</PackageDescription>
<NDC11Code>16590-0889-72</NDC11Code>
<ProductNDC>16590-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1).</IndicationAndUsage>
<Description>NUCYNTA® (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring.</Description>
</NDC>
<NDC>
<NDCCode>24236-889-24</NDCCode>
<PackageDescription>200 TABLET, FILM COATED in 1 CANISTER (24236-889-24)</PackageDescription>
<NDC11Code>24236-0889-24</NDC11Code>
<ProductNDC>24236-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089686</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-889-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-889-30)</PackageDescription>
<NDC11Code>42291-0889-30</NDC11Code>
<ProductNDC>42291-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077655</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>63187-889-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 POUCH (63187-889-28) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63187-0889-28</NDC11Code>
<ProductNDC>63187-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aviane</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20010402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075796</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aviane (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with Aviane (levonorgestrel and ethinyl estradiol tablets USP), 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α -pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. 7 light-green, inert tablets each containing: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Levonorgestrel, USP. Ethinyl Estradiol, USP.</Description>
</NDC>
<NDC>
<NDCCode>65015-889-61</NDCCode>
<PackageDescription>100 kg in 1 DRUM (65015-889-61) </PackageDescription>
<NDC11Code>65015-0889-61</NDC11Code>
<ProductNDC>65015-889</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mafenide Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20181112</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Mylan Laboratories Limited</LabelerName>
<SubstanceName>MAFENIDE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-NOV-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66051-210-50</NDCCode>
<PackageDescription>4 BOTTLE, PLASTIC in 1 BOX (66051-210-50) > 148 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66051-0210-50</NDC11Code>
<ProductNDC>66051-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Haws Eyewash Additive</ProprietaryName>
<NonProprietaryName>Purified Water</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL</RouteName>
<StartMarketingDate>20140703</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Haws Corporation</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>889.6</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To preserve potable water in 5-20 gallons (18.93L-75.7L) self-contained emergency eyewash stations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67457-889-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (67457-889-10) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>67457-0889-10</NDC11Code>
<ProductNDC>67457-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosaprepitant</ProprietaryName>
<NonProprietaryName>Fosaprepitant</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204015</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>FOSAPREPITANT DIMEGLUMINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. , 2 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). .</IndicationAndUsage>
<Description>Fosaprepitant for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phosphonate (2:1) (salt). Its empirical formula is C23H22F7N4O6P⋅2(C7H17NO5) and its structural formula is. Fosaprepitant dimeglumine is a white to off-white amorphous powder with a molecular weight of 1004.83. It is freely soluble in methanol and water, insoluble in acetone and ethanol. Each vial of fosaprepitant for injection for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (18.8 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment).</Description>
</NDC>
<NDC>
<NDCCode>45802-009-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0009-10</NDC11Code>
<ProductNDC>45802-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202849</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide oil ear drops is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Oil, 0.01% Ear Drops contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16, 17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil ear drops contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide oil ear drops is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide oil ear drops is heated just below 232°C (450°F) for at least 15 minutes.</Description>
</NDC>
<NDC>
<NDCCode>45802-078-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>45802-0078-30</NDC11Code>
<ProductNDC>45802-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine</ProprietaryName>
<NonProprietaryName>Brimonidine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209158</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.</IndicationAndUsage>
<Description>Brimonidine Topical Gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C11H10BrN5 C4H6O6. It has the following structural formula. Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of Brimonidine Topical Gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients benzalkonium chloride, carbomer homopolymer type B, glycerin, propylene glycol, purified water, sodium hydroxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>45802-170-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-170-03) > 28.35 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0170-03</NDC11Code>
<ProductNDC>45802-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100817</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-170-53</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-170-53) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0170-53</NDC11Code>
<ProductNDC>45802-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100817</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-170-77</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-170-77) > 198.6 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0170-77</NDC11Code>
<ProductNDC>45802-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea</ProprietaryName>
<NonProprietaryName>Urea</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100817</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>UREA</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-263-37</NDCCode>
<PackageDescription>60 APPLICATOR in 1 JAR (45802-263-37) / 1 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>45802-0263-37</NDC11Code>
<ProductNDC>45802-263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065049</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin Phosphate Topical Solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).</IndicationAndUsage>
<Description>Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>45802-263-93</NDCCode>
<PackageDescription>69 APPLICATOR in 1 JAR (45802-263-93) > 1 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>45802-0263-93</NDC11Code>
<ProductNDC>45802-263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065049</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-303-21</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (45802-303-21) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0303-21</NDC11Code>
<ProductNDC>45802-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088832</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-303-67</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (45802-303-67) > 24 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0303-67</NDC11Code>
<ProductNDC>45802-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088832</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-390-00</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0390-00</NDC11Code>
<ProductNDC>45802-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>45802-390-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0390-01</NDC11Code>
<ProductNDC>45802-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>45802-390-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0390-02</NDC11Code>
<ProductNDC>45802-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>45802-423-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-423-35) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0423-35</NDC11Code>
<ProductNDC>45802-423</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desonide</ProprietaryName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060822</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017426</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
<Description>Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to off-white powder. The solubility of desonide in distilled water saturated with ether is 184 mg/L. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-423-37</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-423-37) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0423-37</NDC11Code>
<ProductNDC>45802-423</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desonide</ProprietaryName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060822</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017426</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
<Description>Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to off-white powder. The solubility of desonide in distilled water saturated with ether is 184 mg/L. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>45802-436-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0436-01</NDC11Code>
<ProductNDC>45802-436</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tazarotene</ProprietaryName>
<NonProprietaryName>Tazarotene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213079</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TAZAROTENE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tazarotene gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1). Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2).</IndicationAndUsage>
<Description>Tazarotene Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of Tazarotene Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene gel contains the following inactive ingredients. benzyl alcohol 1%; ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.</Description>
</NDC>
</NDCList>