{
"NDC": [
{
"NDCCode": "68308-748-18",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68308-748-18) / 18 INSERT in 1 BLISTER PACK",
"NDC11Code": "68308-0748-18",
"ProductNDC": "68308-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imvexxy",
"NonProprietaryName": "Estradiol",
"DosageFormName": "INSERT",
"RouteName": "VAGINAL",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208564",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "10",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250110",
"SamplePackage": "N",
"IndicationAndUsage": "IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).",
"Description": "IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with \"04\" or \"10\" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test."
},
{
"NDCCode": "68308-747-18",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68308-747-18) / 18 INSERT in 1 BLISTER PACK",
"NDC11Code": "68308-0747-18",
"ProductNDC": "68308-747",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imvexxy",
"NonProprietaryName": "Estradiol",
"DosageFormName": "INSERT",
"RouteName": "VAGINAL",
"StartMarketingDate": "20240503",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208564",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "4",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).",
"Description": "IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with \"04\" or \"10\" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test."
},
{
"NDCCode": "68308-748-00",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68308-748-00) / 2 INSERT in 1 BLISTER PACK",
"NDC11Code": "68308-0748-00",
"ProductNDC": "68308-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imvexxy",
"NonProprietaryName": "Estradiol",
"DosageFormName": "INSERT",
"RouteName": "VAGINAL",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208564",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "10",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).",
"Description": "IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with \"04\" or \"10\" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test."
},
{
"NDCCode": "68308-748-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68308-748-08) / 8 INSERT in 1 BLISTER PACK",
"NDC11Code": "68308-0748-08",
"ProductNDC": "68308-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imvexxy",
"NonProprietaryName": "Estradiol",
"DosageFormName": "INSERT",
"RouteName": "VAGINAL",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208564",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "10",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250110",
"SamplePackage": "N",
"IndicationAndUsage": "IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).",
"Description": "IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with \"04\" or \"10\" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test."
},
{
"NDCCode": "11673-748-18",
"PackageDescription": "180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11673-748-18) ",
"NDC11Code": "11673-0748-18",
"ProductNDC": "11673-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20180401",
"EndMarketingDate": "20270828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208363",
"LabelerName": "TARGET Corporation",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180401",
"EndMarketingDatePackage": "20270828",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold. temporarily reduces fever ."
},
{
"NDCCode": "42291-748-18",
"PackageDescription": "18 TABLET, FILM COATED in 1 BOTTLE (42291-748-18) ",
"NDC11Code": "42291-0748-18",
"ProductNDC": "42291-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077342",
"LabelerName": "AvKARE",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181218",
"SamplePackage": "N"
},
{
"NDCCode": "43353-748-52",
"PackageDescription": "18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-748-52)",
"NDC11Code": "43353-0748-52",
"ProductNDC": "43353-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levitra",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021400",
"LabelerName": "APHENA PHARMA SOLUTIONS - TENNESSEE, INC.",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LEVITRA is indicated for the treatment of erectile dysfunction.",
"Description": "LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide."
},
{
"NDCCode": "68308-312-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68308-312-10) ",
"NDC11Code": "68308-0312-10",
"ProductNDC": "68308-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, Caffeine, And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Aspirin, Caffeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203335",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "325; 50; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151030",
"SamplePackage": "N"
},
{
"NDCCode": "68308-502-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (68308-502-60)",
"NDC11Code": "68308-0502-60",
"ProductNDC": "68308-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mi-omega Nf",
"NonProprietaryName": "Multiple Vitamin Capsule",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Midlothian Laboratories, LLC",
"SubstanceName": "FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; OMEGA-3-ACID ETHYL ESTERS; SITOSTEROL, BETA-",
"StrengthNumber": "1; 12.5; 500; 500; 200",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68308-703-01",
"PackageDescription": "1 TUBE in 1 CARTON (68308-703-01) / 100 g in 1 TUBE",
"NDC11Code": "68308-0703-01",
"ProductNDC": "68308-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200744",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211208",
"EndMarketingDatePackage": "20240531",
"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 a molecular 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, paraffin, propylene carbonate, white petrolatum and white wax."
},
{
"NDCCode": "68308-703-60",
"PackageDescription": "1 TUBE in 1 CARTON (68308-703-60) / 60 g in 1 TUBE",
"NDC11Code": "68308-0703-60",
"ProductNDC": "68308-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200744",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211208",
"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 a molecular 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, paraffin, propylene carbonate, white petrolatum and white wax."
},
{
"NDCCode": "68308-752-01",
"PackageDescription": "1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH",
"NDC11Code": "68308-0752-01",
"ProductNDC": "68308-752",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Annovera",
"NonProprietaryName": "Segesterone Acetate And Ethinyl Estradiol",
"DosageFormName": "RING",
"RouteName": "VAGINAL",
"StartMarketingDate": "20240816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209627",
"LabelerName": "Mayne Pharma",
"SubstanceName": "SEGESTERONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "103; 17.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240816",
"SamplePackage": "N",
"IndicationAndUsage": "ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use. ANNOVERA has not been adequately studied in females with a BMI >29 kg/m2.",
"Description": "ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal shaped (ring), nonbiodegradable, flexible, opaque white vaginal system containing two active components, a progestin, segesterone acetate, and an estrogen, ethinyl estradiol. When placed in the vagina, each ANNOVERA releases an approximate average 0.15 mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol over the 21 days in-use period of each cycle for up to 13 cycles (total of 273 days). Each cycle is 28 days, with 21 days in and 7 days out. The inactive ingredients are dibutyltin dilaurate, silicone elastomers, silicone medical adhesive, and titanium dioxide. The elastomers are all methyl siloxane-based polymers. The vaginal system body has an overall diameter of 56 mm and a cross-sectional diameter of 8.4 mm. It contains two channels of approximately 3.0 mm diameter and 27 mm length into which steroid-containing cores are inserted. Each ANNOVERA contains 103 mg of SA distributed throughout both cores and 17.4 mg of EE distributed throughout only one core. The core containing 40% SA and 12% EE of its mass is 3 mm in diameter and 18 mm in length. The core containing 50% SA of its mass is 3 mm in diameter and 11 mm in length. Contact between the cores and the vaginal system body is fixed by coating the channels with silicone medical adhesive before introducing the cores. After insertion of the cores, the channels are sealed with the silicone medical adhesive. The structural formulas and properties for the active components are shown below. STRUCTURAL FORMULAS. Segesterone Acetate (SA). Ethinyl Estradiol (EE). PROPERTIES. Established Name: Segesterone AcetateChemical Name: 16-methylene-17α-acetoxy-19-nor-pregn-4-ene-3,20-dioneMolecular Formula: C23H30O4Molecular Weight: 370.5Physical Form: White, or yellowish white powderSolubility: Slightly soluble in n-hexane, soluble in ethyl acetate and methanol, freely soluble in acetone (USP classification) Melting Point: 173°C–177°C. Established Name: Ethinyl EstradiolChemical Name: 19-Nor-17α -pregna-1,3,5(10)-trien-20-yne-3,17-diolMolecular Formula: C20H24O2Molecular Weight: 296.4Physical Form: White to slightly yellowish-white crystalline powderSolubility: Practically insoluble in water, freely soluble in alcohol, it dissolves in alkaline solutionMelting Point: 181°C–185°C. The steroids diffuse out of the vaginal system with release rates that vary over time. Based on in vitro data, the daily release rates of SA and EE are higher during each initial 24–48 hours of use achieving a somewhat lower steady-state with continued use over the subsequent days in each cycle. The vaginal system is designed to be used for 13 cycles (1 year) on a 21/7 days in/out schedule. The total in-use time with the 21/7 days in/out schedule over 13 cycles is 273 days. Based on the residual amount of drug in vaginal systems used in clinical trials over 13 cycles, a total of 41.3 mg of SA and 3.4 mg of EE are released over this period. This translates to an approximate average daily dose of 0.15 mg of segesterone acetate and 0.013 mg of ethinyl estradiol with higher release rate expected at the beginning of dosing and a lower release rate toward the end."
},
{
"NDCCode": "68308-771-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68308-771-30) / 30 g in 1 BOTTLE, PUMP",
"NDC11Code": "68308-0771-30",
"ProductNDC": "68308-771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Twyneo",
"NonProprietaryName": "Benzoyl Peroxide And Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214902",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "BENZOYL PEROXIDE; TRETINOIN",
"StrengthNumber": "30; 1",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.",
"Description": "TWYNEO (tretinoin and benzoyl peroxide) cream is a yellow cream for topical use. Each gram of TWYNEO contains 1 mg (0.1%) of tretinoin and 30 mg (3%) of benzoyl peroxide. Tretinoin is a retinoid and benzoyl peroxide is an oxidizing agent. The chemical name for tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7- dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin has the following structural formula. The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. Benzoyl peroxide has the following structural formula. The formulation of TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the. TWYNEO contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer type C, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, imidurea, (S)lactic acid, macrogol stearate, mono and di-glycerides, polyquaternium-7, purified water, silicon dioxide, sodium hydroxide, squalane, tetraethyl ortho silicate and white wax."
},
{
"NDCCode": "68308-772-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68308-772-30) / 30 g in 1 BOTTLE, PUMP",
"NDC11Code": "68308-0772-30",
"ProductNDC": "68308-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epsolay",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214510",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.",
"Description": "EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide. The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. It has the following structural formula. The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into a microcapsule composed of silicon dioxide, cetrimonium chloride and polyquaternium-7. EPSOLAY contains anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide as inactive ingredients."
},
{
"NDCCode": "59088-748-00",
"PackageDescription": "1 KIT in 1 KIT (59088-748-00) * 1 TUBE in 1 CARTON (45802-151-94) > 30 g in 1 TUBE * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) ",
"NDC11Code": "59088-0748-00",
"ProductNDC": "59088-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hexicinide",
"NonProprietaryName": "Hexicinide",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090256",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140114",
"SamplePackage": "N"
},
{
"NDCCode": "68382-748-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-01) ",
"NDC11Code": "68382-0748-01",
"ProductNDC": "68382-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18."
},
{
"NDCCode": "68382-748-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-05) ",
"NDC11Code": "68382-0748-05",
"ProductNDC": "68382-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18."
},
{
"NDCCode": "68382-748-06",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-06) ",
"NDC11Code": "68382-0748-06",
"ProductNDC": "68382-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18."
},
{
"NDCCode": "68382-748-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-10) ",
"NDC11Code": "68382-0748-10",
"ProductNDC": "68382-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18."
},
{
"NDCCode": "68382-748-16",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-16) ",
"NDC11Code": "68382-0748-16",
"ProductNDC": "68382-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18."
},
{
"NDCCode": "69039-748-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69039-748-02) / 50 mL in 1 BOTTLE, PLASTIC (69039-748-01) ",
"NDC11Code": "69039-0748-02",
"ProductNDC": "69039-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Bum Mineral 30 Sheer Sunscreen Face",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sun Bum, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "192",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "72450-748-01",
"PackageDescription": "100 kg in 1 DRUM (72450-748-01) ",
"NDC11Code": "72450-0748-01",
"ProductNDC": "72450-748",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180413",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Elementis SRL, Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-03-23",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-APR-18"
},
{
"NDCCode": "72450-748-02",
"PackageDescription": "635 kg in 1 SUPERSACK (72450-748-02) ",
"NDC11Code": "72450-0748-02",
"ProductNDC": "72450-748",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180413",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Elementis SRL, Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-03-23",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-APR-18"
},
{
"NDCCode": "72450-748-03",
"PackageDescription": "815 kg in 1 SUPERSACK (72450-748-03) ",
"NDC11Code": "72450-0748-03",
"ProductNDC": "72450-748",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180413",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Elementis SRL, Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-03-23",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-APR-18"
},
{
"NDCCode": "72450-748-04",
"PackageDescription": "544 kg in 1 SUPERSACK (72450-748-04) ",
"NDC11Code": "72450-0748-04",
"ProductNDC": "72450-748",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180413",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Elementis SRL, Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-03-23",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-APR-18"
},
{
"NDCCode": "75071-748-01",
"PackageDescription": "4.25 g in 1 TUBE (75071-748-01) ",
"NDC11Code": "75071-0748-01",
"ProductNDC": "75071-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Nethercutt Collection Hemp Vanilla Spf 30 Broad Spectrum Sunscreen Lip Balm",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Oxybenzone",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240318",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Eco Lips. Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTISALATE",
"StrengthNumber": "7.5; 4; 3; 5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2024-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240318",
"SamplePackage": "N",
"IndicationAndUsage": "Use helps prevent sunburn."
},
{
"NDCCode": "68308-020-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (68308-020-03) / 30 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "68308-0020-03",
"ProductNDC": "68308-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204092",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140612",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, 100 mg per 5 mL (20 mg/mL) include: citric acid anhydrous, D&C Yellow #10, natural/artificial berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, and sorbitol."
},
{
"NDCCode": "68308-108-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (68308-108-01) ",
"NDC11Code": "68308-0108-01",
"ProductNDC": "68308-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091313",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N"
},
{
"NDCCode": "68308-110-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (68308-110-01) ",
"NDC11Code": "68308-0110-01",
"ProductNDC": "68308-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091313",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160429",
"SamplePackage": "N"
},
{
"NDCCode": "68308-111-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (68308-111-01) ",
"NDC11Code": "68308-0111-01",
"ProductNDC": "68308-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091313",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68308-748-18</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68308-748-18) / 18 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0748-18</NDC11Code>
<ProductNDC>68308-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imvexxy</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208564</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).</IndicationAndUsage>
<Description>IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test.</Description>
</NDC>
<NDC>
<NDCCode>68308-747-18</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68308-747-18) / 18 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0747-18</NDC11Code>
<ProductNDC>68308-747</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imvexxy</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20240503</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208564</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).</IndicationAndUsage>
<Description>IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test.</Description>
</NDC>
<NDC>
<NDCCode>68308-748-00</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68308-748-00) / 2 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0748-00</NDC11Code>
<ProductNDC>68308-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imvexxy</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208564</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).</IndicationAndUsage>
<Description>IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test.</Description>
</NDC>
<NDC>
<NDCCode>68308-748-08</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68308-748-08) / 8 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0748-08</NDC11Code>
<ProductNDC>68308-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imvexxy</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208564</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).</IndicationAndUsage>
<Description>IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test.</Description>
</NDC>
<NDC>
<NDCCode>11673-748-18</NDCCode>
<PackageDescription>180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11673-748-18) </PackageDescription>
<NDC11Code>11673-0748-18</NDC11Code>
<ProductNDC>11673-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180401</StartMarketingDate>
<EndMarketingDate>20270828</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208363</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180401</StartMarketingDatePackage>
<EndMarketingDatePackage>20270828</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold. temporarily reduces fever .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-748-18</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BOTTLE (42291-748-18) </PackageDescription>
<NDC11Code>42291-0748-18</NDC11Code>
<ProductNDC>42291-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077342</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43353-748-52</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-748-52)</PackageDescription>
<NDC11Code>43353-0748-52</NDC11Code>
<ProductNDC>43353-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levitra</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021400</ApplicationNumber>
<LabelerName>APHENA PHARMA SOLUTIONS - TENNESSEE, INC.</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LEVITRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>68308-312-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68308-312-10) </PackageDescription>
<NDC11Code>68308-0312-10</NDC11Code>
<ProductNDC>68308-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, Caffeine, And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Caffeine, And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203335</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>325; 50; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-502-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68308-502-60)</PackageDescription>
<NDC11Code>68308-0502-60</NDC11Code>
<ProductNDC>68308-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mi-omega Nf</ProprietaryName>
<NonProprietaryName>Multiple Vitamin Capsule</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Midlothian Laboratories, LLC</LabelerName>
<SubstanceName>FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; OMEGA-3-ACID ETHYL ESTERS; SITOSTEROL, BETA-</SubstanceName>
<StrengthNumber>1; 12.5; 500; 500; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68308-703-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68308-703-01) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>68308-0703-01</NDC11Code>
<ProductNDC>68308-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200744</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211208</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<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 a molecular 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, paraffin, propylene carbonate, white petrolatum and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68308-703-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68308-703-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>68308-0703-60</NDC11Code>
<ProductNDC>68308-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200744</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211208</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 a molecular 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, paraffin, propylene carbonate, white petrolatum and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68308-752-01</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH</PackageDescription>
<NDC11Code>68308-0752-01</NDC11Code>
<ProductNDC>68308-752</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Annovera</ProprietaryName>
<NonProprietaryName>Segesterone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>RING</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20240816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209627</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>SEGESTERONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>103; 17.4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use. ANNOVERA has not been adequately studied in females with a BMI >29 kg/m2.</IndicationAndUsage>
<Description>ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal shaped (ring), nonbiodegradable, flexible, opaque white vaginal system containing two active components, a progestin, segesterone acetate, and an estrogen, ethinyl estradiol. When placed in the vagina, each ANNOVERA releases an approximate average 0.15 mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol over the 21 days in-use period of each cycle for up to 13 cycles (total of 273 days). Each cycle is 28 days, with 21 days in and 7 days out. The inactive ingredients are dibutyltin dilaurate, silicone elastomers, silicone medical adhesive, and titanium dioxide. The elastomers are all methyl siloxane-based polymers. The vaginal system body has an overall diameter of 56 mm and a cross-sectional diameter of 8.4 mm. It contains two channels of approximately 3.0 mm diameter and 27 mm length into which steroid-containing cores are inserted. Each ANNOVERA contains 103 mg of SA distributed throughout both cores and 17.4 mg of EE distributed throughout only one core. The core containing 40% SA and 12% EE of its mass is 3 mm in diameter and 18 mm in length. The core containing 50% SA of its mass is 3 mm in diameter and 11 mm in length. Contact between the cores and the vaginal system body is fixed by coating the channels with silicone medical adhesive before introducing the cores. After insertion of the cores, the channels are sealed with the silicone medical adhesive. The structural formulas and properties for the active components are shown below. STRUCTURAL FORMULAS. Segesterone Acetate (SA). Ethinyl Estradiol (EE). PROPERTIES. Established Name: Segesterone AcetateChemical Name: 16-methylene-17α-acetoxy-19-nor-pregn-4-ene-3,20-dioneMolecular Formula: C23H30O4Molecular Weight: 370.5Physical Form: White, or yellowish white powderSolubility: Slightly soluble in n-hexane, soluble in ethyl acetate and methanol, freely soluble in acetone (USP classification) Melting Point: 173°C–177°C. Established Name: Ethinyl EstradiolChemical Name: 19-Nor-17α -pregna-1,3,5(10)-trien-20-yne-3,17-diolMolecular Formula: C20H24O2Molecular Weight: 296.4Physical Form: White to slightly yellowish-white crystalline powderSolubility: Practically insoluble in water, freely soluble in alcohol, it dissolves in alkaline solutionMelting Point: 181°C–185°C. The steroids diffuse out of the vaginal system with release rates that vary over time. Based on in vitro data, the daily release rates of SA and EE are higher during each initial 24–48 hours of use achieving a somewhat lower steady-state with continued use over the subsequent days in each cycle. The vaginal system is designed to be used for 13 cycles (1 year) on a 21/7 days in/out schedule. The total in-use time with the 21/7 days in/out schedule over 13 cycles is 273 days. Based on the residual amount of drug in vaginal systems used in clinical trials over 13 cycles, a total of 41.3 mg of SA and 3.4 mg of EE are released over this period. This translates to an approximate average daily dose of 0.15 mg of segesterone acetate and 0.013 mg of ethinyl estradiol with higher release rate expected at the beginning of dosing and a lower release rate toward the end.</Description>
</NDC>
<NDC>
<NDCCode>68308-771-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68308-771-30) / 30 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>68308-0771-30</NDC11Code>
<ProductNDC>68308-771</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Twyneo</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide And Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214902</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; TRETINOIN</SubstanceName>
<StrengthNumber>30; 1</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.</IndicationAndUsage>
<Description>TWYNEO (tretinoin and benzoyl peroxide) cream is a yellow cream for topical use. Each gram of TWYNEO contains 1 mg (0.1%) of tretinoin and 30 mg (3%) of benzoyl peroxide. Tretinoin is a retinoid and benzoyl peroxide is an oxidizing agent. The chemical name for tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7- dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin has the following structural formula. The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. Benzoyl peroxide has the following structural formula. The formulation of TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the. TWYNEO contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer type C, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, imidurea, (S)lactic acid, macrogol stearate, mono and di-glycerides, polyquaternium-7, purified water, silicon dioxide, sodium hydroxide, squalane, tetraethyl ortho silicate and white wax.</Description>
</NDC>
<NDC>
<NDCCode>68308-772-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68308-772-30) / 30 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>68308-0772-30</NDC11Code>
<ProductNDC>68308-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epsolay</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214510</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.</IndicationAndUsage>
<Description>EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide. The chemical name for benzoyl peroxide is benzoyl benzenecarboperoxoate. It has the following structural formula. The benzoyl peroxide in EPSOLAY is in a solid form that is incorporated into a microcapsule composed of silicon dioxide, cetrimonium chloride and polyquaternium-7. EPSOLAY contains anhydrous citric acid, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, lactic acid, macrogol stearate Type I, mono and di-glycerides, phenoxyethanol, polyquaternium-7, purified water, silicon dioxide and sodium hydroxide as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>59088-748-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-748-00) * 1 TUBE in 1 CARTON (45802-151-94) > 30 g in 1 TUBE * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) </PackageDescription>
<NDC11Code>59088-0748-00</NDC11Code>
<ProductNDC>59088-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hexicinide</ProprietaryName>
<NonProprietaryName>Hexicinide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090256</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-748-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-01) </PackageDescription>
<NDC11Code>68382-0748-01</NDC11Code>
<ProductNDC>68382-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiadylt Er</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206641</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18.</Description>
</NDC>
<NDC>
<NDCCode>68382-748-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-05) </PackageDescription>
<NDC11Code>68382-0748-05</NDC11Code>
<ProductNDC>68382-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiadylt Er</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206641</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18.</Description>
</NDC>
<NDC>
<NDCCode>68382-748-06</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-06) </PackageDescription>
<NDC11Code>68382-0748-06</NDC11Code>
<ProductNDC>68382-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiadylt Er</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206641</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18.</Description>
</NDC>
<NDC>
<NDCCode>68382-748-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-10) </PackageDescription>
<NDC11Code>68382-0748-10</NDC11Code>
<ProductNDC>68382-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiadylt Er</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206641</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18.</Description>
</NDC>
<NDC>
<NDCCode>68382-748-16</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-16) </PackageDescription>
<NDC11Code>68382-0748-16</NDC11Code>
<ProductNDC>68382-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiadylt Er</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206641</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18.</Description>
</NDC>
<NDC>
<NDCCode>69039-748-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69039-748-02) / 50 mL in 1 BOTTLE, PLASTIC (69039-748-01) </PackageDescription>
<NDC11Code>69039-0748-02</NDC11Code>
<ProductNDC>69039-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Bum Mineral 30 Sheer Sunscreen Face</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Sun Bum, LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>192</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72450-748-01</NDCCode>
<PackageDescription>100 kg in 1 DRUM (72450-748-01) </PackageDescription>
<NDC11Code>72450-0748-01</NDC11Code>
<ProductNDC>72450-748</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180413</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Elementis SRL, Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-23</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-APR-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>72450-748-02</NDCCode>
<PackageDescription>635 kg in 1 SUPERSACK (72450-748-02) </PackageDescription>
<NDC11Code>72450-0748-02</NDC11Code>
<ProductNDC>72450-748</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180413</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Elementis SRL, Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-23</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-APR-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>72450-748-03</NDCCode>
<PackageDescription>815 kg in 1 SUPERSACK (72450-748-03) </PackageDescription>
<NDC11Code>72450-0748-03</NDC11Code>
<ProductNDC>72450-748</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180413</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Elementis SRL, Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-23</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-APR-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>72450-748-04</NDCCode>
<PackageDescription>544 kg in 1 SUPERSACK (72450-748-04) </PackageDescription>
<NDC11Code>72450-0748-04</NDC11Code>
<ProductNDC>72450-748</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180413</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Elementis SRL, Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-23</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-APR-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>75071-748-01</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (75071-748-01) </PackageDescription>
<NDC11Code>75071-0748-01</NDC11Code>
<ProductNDC>75071-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Nethercutt Collection Hemp Vanilla Spf 30 Broad Spectrum Sunscreen Lip Balm</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Oxybenzone</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240318</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Eco Lips. Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTISALATE</SubstanceName>
<StrengthNumber>7.5; 4; 3; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68308-020-03</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (68308-020-03) / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68308-0020-03</NDC11Code>
<ProductNDC>68308-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204092</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, 100 mg per 5 mL (20 mg/mL) include: citric acid anhydrous, D&C Yellow #10, natural/artificial berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>68308-108-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (68308-108-01) </PackageDescription>
<NDC11Code>68308-0108-01</NDC11Code>
<ProductNDC>68308-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091313</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-05-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-110-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (68308-110-01) </PackageDescription>
<NDC11Code>68308-0110-01</NDC11Code>
<ProductNDC>68308-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091313</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-05-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68308-111-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (68308-111-01) </PackageDescription>
<NDC11Code>68308-0111-01</NDC11Code>
<ProductNDC>68308-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091313</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-05-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>