{
"NDC": [
{
"NDCCode": "85273-215-00",
"PackageDescription": "6 KIT in 1 BOX (85273-215-00) / 1 KIT in 1 KIT * 60 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (84132-100-10) * 53 mL in 1 BOTTLE, PLASTIC (59448-011-01) ",
"NDC11Code": "85273-0215-00",
"ProductNDC": "85273-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Northside Hospital Maternity Backpack Base",
"NonProprietaryName": "Sodium Monofluorophospate",
"DosageFormName": "KIT",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ALLIANCE FORMULATIONS",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N"
},
{
"NDCCode": "10544-215-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (10544-215-00)",
"NDC11Code": "10544-0215-00",
"ProductNDC": "10544-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "17314-215-00",
"PackageDescription": "15202 TABLET, FILM COATED in 1 DRUM (17314-215-00) ",
"NDC11Code": "17314-0215-00",
"ProductNDC": "17314-215",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Apalutamide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20180214",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Janssen Ortho LLC",
"SubstanceName": "APALUTAMIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-04-05",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "14-FEB-18"
},
{
"NDCCode": "21130-215-00",
"PackageDescription": "130 g in 1 CAN (21130-215-00) ",
"NDC11Code": "21130-0215-00",
"ProductNDC": "21130-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tolnafate",
"NonProprietaryName": "Tolnaftate Powder Spray",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210927",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Better Living Brands LLC",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "1.3",
"StrengthUnit": "g/130g",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210927",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking."
},
{
"NDCCode": "50988-215-00",
"PackageDescription": "331.22 mL in 1 BOTTLE, PUMP (50988-215-00)",
"NDC11Code": "50988-0215-00",
"ProductNDC": "50988-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Soap",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100803",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Jets, Sets, & Elephants Beauty Corp.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".994",
"StrengthUnit": "mL/331.22mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "handwashing to decrease bacteria on skin."
},
{
"NDCCode": "51815-215-00",
"PackageDescription": "73 g in 1 PACKAGE (51815-215-00)",
"NDC11Code": "51815-0215-00",
"ProductNDC": "51815-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Right Guard Xtreme Clear",
"ProprietaryNameSuffix": "Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "VVF Illinois Services LLC",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "13.87",
"StrengthUnit": "g/73g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Reduces underarm perspiration."
},
{
"NDCCode": "59448-215-00",
"PackageDescription": "6 BAG in 1 BOX (59448-215-00) / 1 KIT in 1 BAG * 60 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (84132-100-10) * 53 mL in 1 BOTTLE, PLASTIC (59448-011-01) ",
"NDC11Code": "59448-0215-00",
"ProductNDC": "59448-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Northside Hospital Maternity Backpack-base",
"NonProprietaryName": "Alcohol And Sodium Monofluorophosphate",
"DosageFormName": "KIT",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ASP Global, LLc",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N"
},
{
"NDCCode": "61197-215-00",
"PackageDescription": "118 mL in 1 BOTTLE, SPRAY (61197-215-00) ",
"NDC11Code": "61197-0215-00",
"ProductNDC": "61197-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Set And Protect Matte Sheer Setting Mist Spf 45",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Pacifica Beauty, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2.9; 9.8; 4.9; 9.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"IndicationAndUsage": "If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun."
},
{
"NDCCode": "63552-215-00",
"PackageDescription": "120 VIAL in 1 CASE (63552-215-00) / 10 mL in 1 VIAL",
"NDC11Code": "63552-0215-00",
"ProductNDC": "63552-215",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Foscarbidopa/foslevodopa",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20241017",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Manufacturing Services LLC",
"SubstanceName": "FOSCARBIDOPA; FOSLEVODOPA",
"StrengthNumber": "12; 240",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Unfinished",
"LastUpdate": "2025-02-20",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "17-OCT-24"
},
{
"NDCCode": "65364-215-00",
"PackageDescription": "1 TUBE in 1 CARTON (65364-215-00) > 100 mL in 1 TUBE",
"NDC11Code": "65364-0215-00",
"ProductNDC": "65364-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kiss My Face Organics Kids Mineral Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150109",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kiss My Face LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "60; 60",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-10-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "68001-215-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (68001-215-00)",
"NDC11Code": "68001-0215-00",
"ProductNDC": "68001-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072011",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69491-215-00",
"PackageDescription": "1 KIT in 1 KIT (69491-215-00) * 10 g in 1 TUBE (42555-060-45) * 14 g in 1 TUBE (64942-1343-2) ",
"NDC11Code": "69491-0215-00",
"ProductNDC": "69491-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Delta Ron 2019 Amenity With Colgate Cavity Protection",
"NonProprietaryName": "Sodium Monofluorophosphate, Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "KIT",
"StartMarketingDate": "20190401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Buzz Export Services Pty., Ltd.",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190401",
"SamplePackage": "N"
},
{
"NDCCode": "78804-215-00",
"PackageDescription": "300 PACKAGE in 1 BOX (78804-215-00) > .8 g in 1 PACKAGE",
"NDC11Code": "78804-0215-00",
"ProductNDC": "78804-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ameriwipes Disinfectant Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Allure Chemicals LP",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Use this product as a convenient way to clean and disinfect your household surfaces."
},
{
"NDCCode": "49281-182-25",
"PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-182-25) > .25 mL in 1 SYRINGE, GLASS (49281-182-00) ",
"NDC11Code": "49281-0182-25",
"ProductNDC": "49281-182",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20210204",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210204",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "49281-521-25",
"PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-521-25) > .25 mL in 1 SYRINGE, GLASS (49281-521-00) ",
"NDC11Code": "49281-0521-25",
"ProductNDC": "49281-521",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Quadrivalent",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20210702",
"EndMarketingDate": "20220630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210702",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "50090-2259-0",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (50090-2259-0) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50090-2259-00",
"ProductNDC": "50090-2259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norgestimate And Ethinyl Estradiol",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20120406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200538",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151209",
"SamplePackage": "N",
"IndicationAndUsage": "Norgestimate and ethinyl estradiol tablets are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg: 1 Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, FD&C Blue No. 2, colloidal silicon dioxide, talc, magnesium stearate, and pregelatinized starch., 2 Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc."
},
{
"NDCCode": "50090-2326-0",
"PackageDescription": "1 KIT in 1 KIT (50090-2326-0) ",
"NDC11Code": "50090-2326-00",
"ProductNDC": "50090-2326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-lo-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20151230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076784",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160310",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)‑ (+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active gray tablet contains 0.18 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, black iron oxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 2 Each active light blue tablet contains 0.215 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 4 Each white tablet contains only inert ingredients, as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "50090-2429-0",
"PackageDescription": "1 KIT in 1 KIT (50090-2429-0) ",
"NDC11Code": "50090-2429-00",
"ProductNDC": "50090-2429",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-lo-marzia",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20200108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200541",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200108",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Lo-Marzia is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Tri-Lo-Marzia is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as ((+)-13-Ethyl-17-hydroxy-18, 19-dinor-17a-pregn-4-en-20-yn-3-one oxime acetate (ester)) and ethinyl estradiol is designated as (19-nor-17a-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white film-coated tablet contains 0.18 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 2 Each active light blue film-coated tablet contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 3 Each active blue film-coated tablet contains 0.25 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 4 Each green film-coated tablet contains only inert ingredients, as follows: croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "50090-2603-0",
"PackageDescription": "1 KIT in 1 KIT (50090-2603-0) ",
"NDC11Code": "50090-2603-00",
"ProductNDC": "50090-2603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norgestimate And Ethinyl Estradiol",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20110617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200494",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161108",
"SamplePackage": "N",
"IndicationAndUsage": "Norgestimate and ethinyl estradiol tablets are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1). Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg: 1 Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, FD&C Blue No. 2, colloidal silicon dioxide, talc, magnesium stearate, and pregelatinized starch., 2 Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc."
},
{
"NDCCode": "50090-3239-0",
"PackageDescription": "1 KIT in 1 KIT (50090-3239-0) ",
"NDC11Code": "50090-3239-00",
"ProductNDC": "50090-3239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri Femynor",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20161028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203870",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171102",
"SamplePackage": "N",
"IndicationAndUsage": "Tri Femynor is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1). Tri Femynor is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive birth control. (1.2).",
"Description": "Tri Femynor (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each light pink “active” tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 2 Each light red “active” tablet contains 0.215 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 3 Each red “active” tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 4 Each white placebo tablet contains only inert ingredients, as follows: hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, talc and titanium dioxide."
},
{
"NDCCode": "50090-3413-0",
"PackageDescription": "1 KIT in 1 KIT (50090-3413-0) ",
"NDC11Code": "50090-3413-00",
"ProductNDC": "50090-3413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri Femynor",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20161028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203870",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180322",
"SamplePackage": "N",
"IndicationAndUsage": "Tri Femynor is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1). Tri Femynor is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive birth control. (1.2).",
"Description": "Tri Femynor (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each light pink “active” tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 2 Each light red “active” tablet contains 0.215 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 3 Each red “active” tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 4 Each white placebo tablet contains only inert ingredients, as follows: hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, talc and titanium dioxide."
},
{
"NDCCode": "50090-3733-0",
"PackageDescription": "1 KIT in 1 KIT (50090-3733-0) ",
"NDC11Code": "50090-3733-00",
"ProductNDC": "50090-3733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norgestimate And Ethinyl Estradiol",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204057",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181026",
"SamplePackage": "N",
"IndicationAndUsage": "Norgestimate and ethinyl estradiol tablets are an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Norgestimate and Ethinyl Estradiol Tablets USP are a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white to off-white tablet contains 0.18 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K-30, polyethylene glycol, polusorbate 80, talc, titanium dioxide and vitamin E., 2 Each active light blue tablet contains 0.215 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, FD & C blue #2, FD & C blue #1, FD & C red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K-30, polyethylene glycol, polusorbate 80, talc, titanium dioxide and vitamin E., 3 Each active blue tablet contains 0.25 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, FD & C Blue #2, FD & C blue #1, FD & C red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K-30, polyethylene glycol, polysorbate 80, talc, titanium dioxide and vitamin E., 4 Each green to dark green placebo tablet contains only inert ingredients, as follows: anhydrous lactose, FD&C Blue #2, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrilin potassium, polyethylene glycol, polysorbate 80, talc, and titanium dioxide., 5 ."
},
{
"NDCCode": "50090-4203-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-4203-0) ",
"NDC11Code": "50090-4203-00",
"ProductNDC": "50090-4203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090058",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190319",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, talc, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, talc, iron oxide red, yellow iron oxide, and FD&C yellow #6 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol, talc and black iron oxide (10 mg tablets)."
},
{
"NDCCode": "50090-4434-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-4434-0) ",
"NDC11Code": "50090-4434-00",
"ProductNDC": "50090-4434",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200022",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg of memantine hydrochloride and as capsule-shaped, film-coated tablets containing 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, povidone, crospovidone and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coating: hypromellose, titanium dioxide and polyethylene glycol 4000."
},
{
"NDCCode": "50090-4877-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-4877-0) ",
"NDC11Code": "50090-4877-00",
"ProductNDC": "50090-4877",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207236",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200206",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a white, crystalline powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: Microcrystalline Cellulose, NF, Dibasic Calcium Phosphate Anhydrous, USP, Croscarmellose Sodium, NF, Colloidal Silicon Dioxide, NF, Magnesium Stearate, NF. In addition the following inactive ingredients are also present as components of the film coat: Hypromellose 2910 NF, Titanium Dioxide, NF, Polyethylene Glycol, NF, FD&C Yellow 6 Aluminum Lake, FD&C Blue 2 Aluminum Lake (5 mg tablets), and Hypromellose 2910 NF, Titanium Dioxide, Triacetin, NF, Black Iron Oxide, NF, Yellow Iron Oxide, NF, Red Iron Oxide, NF (10 mg tablets)."
},
{
"NDCCode": "50090-5832-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5832-0) ",
"NDC11Code": "50090-5832-00",
"ProductNDC": "50090-5832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202840",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211027",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "50090-5926-0",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-5926-0) ",
"NDC11Code": "50090-5926-00",
"ProductNDC": "50090-5926",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200022",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg of memantine hydrochloride and as capsule-shaped, film-coated tablets containing 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, povidone, crospovidone and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coating: hypromellose, titanium dioxide and polyethylene glycol 4000."
},
{
"NDCCode": "50090-6291-0",
"PackageDescription": "60 TABLET in 1 BOTTLE (50090-6291-0) ",
"NDC11Code": "50090-6291-00",
"ProductNDC": "50090-6291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090961",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221221",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP is a white crystalline powder, soluble in water and in methanol, practically insoluble in acetone. Each memantine hydrochloride tablet, USP intended for oral administration contains 5 mg or 10 mg of memantine hydrochloride. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide."
},
{
"NDCCode": "50090-6400-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-6400-0) ",
"NDC11Code": "50090-6400-00",
"ProductNDC": "50090-6400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206528",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230316",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a fine white to off-white powder and is soluble in water.Memantine Tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, talc and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc, FD & C yellow #6/sunset yellow FCF aluminum lake (5 mg tablets), and polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc and iron oxide black (10 mg tablets). USP Assay test pending."
},
{
"NDCCode": "50090-7348-0",
"PackageDescription": "60 TABLET in 1 BOTTLE (50090-7348-0) ",
"NDC11Code": "50090-7348-00",
"ProductNDC": "50090-7348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204389",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241016",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride tablets, USP are an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21N.HCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white powder and is freely soluble in methanol, soluble in water and sparingly soluble in dimethylformamide. Memantine hydrochloride tablets USP are available for oral administration as modified capsule shaped, film coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, isopropyl alcohol, lactose monohydrate, magnesium stearate, povidone and talc. The 5 mg tablets are coated with Opadry Orange which contains FD & C blue # 2, FD & C yellow # 6, hypromellose, polyethylene glycol and titanium dioxide, 10 mg tablets are coated with Opadry Grey which contains hypromellose, iron oxide black, polyethylene glycol and titanium dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>85273-215-00</NDCCode>
<PackageDescription>6 KIT in 1 BOX (85273-215-00) / 1 KIT in 1 KIT * 60 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (84132-100-10) * 53 mL in 1 BOTTLE, PLASTIC (59448-011-01) </PackageDescription>
<NDC11Code>85273-0215-00</NDC11Code>
<ProductNDC>85273-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Northside Hospital Maternity Backpack Base</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophospate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ALLIANCE FORMULATIONS</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10544-215-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10544-215-00)</PackageDescription>
<NDC11Code>10544-0215-00</NDC11Code>
<ProductNDC>10544-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>17314-215-00</NDCCode>
<PackageDescription>15202 TABLET, FILM COATED in 1 DRUM (17314-215-00) </PackageDescription>
<NDC11Code>17314-0215-00</NDC11Code>
<ProductNDC>17314-215</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Apalutamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20180214</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Janssen Ortho LLC</LabelerName>
<SubstanceName>APALUTAMIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-04-05</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-FEB-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>21130-215-00</NDCCode>
<PackageDescription>130 g in 1 CAN (21130-215-00) </PackageDescription>
<NDC11Code>21130-0215-00</NDC11Code>
<ProductNDC>21130-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tolnafate</ProprietaryName>
<NonProprietaryName>Tolnaftate Powder Spray</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Better Living Brands LLC</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/130g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50988-215-00</NDCCode>
<PackageDescription>331.22 mL in 1 BOTTLE, PUMP (50988-215-00)</PackageDescription>
<NDC11Code>50988-0215-00</NDC11Code>
<ProductNDC>50988-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Soap</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Jets, Sets, & Elephants Beauty Corp.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.994</StrengthNumber>
<StrengthUnit>mL/331.22mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>handwashing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51815-215-00</NDCCode>
<PackageDescription>73 g in 1 PACKAGE (51815-215-00)</PackageDescription>
<NDC11Code>51815-0215-00</NDC11Code>
<ProductNDC>51815-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Right Guard Xtreme Clear</ProprietaryName>
<ProprietaryNameSuffix>Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>VVF Illinois Services LLC</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>13.87</StrengthNumber>
<StrengthUnit>g/73g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59448-215-00</NDCCode>
<PackageDescription>6 BAG in 1 BOX (59448-215-00) / 1 KIT in 1 BAG * 60 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (84132-100-10) * 53 mL in 1 BOTTLE, PLASTIC (59448-011-01) </PackageDescription>
<NDC11Code>59448-0215-00</NDC11Code>
<ProductNDC>59448-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Northside Hospital Maternity Backpack-base</ProprietaryName>
<NonProprietaryName>Alcohol And Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ASP Global, LLc</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61197-215-00</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, SPRAY (61197-215-00) </PackageDescription>
<NDC11Code>61197-0215-00</NDC11Code>
<ProductNDC>61197-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Set And Protect Matte Sheer Setting Mist Spf 45</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Pacifica Beauty, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2.9; 9.8; 4.9; 9.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63552-215-00</NDCCode>
<PackageDescription>120 VIAL in 1 CASE (63552-215-00) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>63552-0215-00</NDC11Code>
<ProductNDC>63552-215</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Foscarbidopa/foslevodopa</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<StartMarketingDate>20241017</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon Manufacturing Services LLC</LabelerName>
<SubstanceName>FOSCARBIDOPA; FOSLEVODOPA</SubstanceName>
<StrengthNumber>12; 240</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-02-20</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-OCT-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65364-215-00</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (65364-215-00) > 100 mL in 1 TUBE</PackageDescription>
<NDC11Code>65364-0215-00</NDC11Code>
<ProductNDC>65364-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kiss My Face Organics Kids Mineral Sunscreen Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Kiss My Face LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>60; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68001-215-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68001-215-00)</PackageDescription>
<NDC11Code>68001-0215-00</NDC11Code>
<ProductNDC>68001-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072011</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69491-215-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (69491-215-00) * 10 g in 1 TUBE (42555-060-45) * 14 g in 1 TUBE (64942-1343-2) </PackageDescription>
<NDC11Code>69491-0215-00</NDC11Code>
<ProductNDC>69491-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Delta Ron 2019 Amenity With Colgate Cavity Protection</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate, Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Buzz Export Services Pty., Ltd.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78804-215-00</NDCCode>
<PackageDescription>300 PACKAGE in 1 BOX (78804-215-00) > .8 g in 1 PACKAGE</PackageDescription>
<NDC11Code>78804-0215-00</NDC11Code>
<ProductNDC>78804-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ameriwipes Disinfectant Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Allure Chemicals LP</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use this product as a convenient way to clean and disinfect your household surfaces.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49281-182-25</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-182-25) > .25 mL in 1 SYRINGE, GLASS (49281-182-00) </PackageDescription>
<NDC11Code>49281-0182-25</NDC11Code>
<ProductNDC>49281-182</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20210204</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210204</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49281-521-25</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-521-25) > .25 mL in 1 SYRINGE, GLASS (49281-521-00) </PackageDescription>
<NDC11Code>49281-0521-25</NDC11Code>
<ProductNDC>49281-521</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Quadrivalent</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20210702</StartMarketingDate>
<EndMarketingDate>20220630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210702</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-2259-0</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (50090-2259-0) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-2259-00</NDC11Code>
<ProductNDC>50090-2259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norgestimate And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200538</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norgestimate and ethinyl estradiol tablets are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg: 1 Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, FD&C Blue No. 2, colloidal silicon dioxide, talc, magnesium stearate, and pregelatinized starch., 2 Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc.</Description>
</NDC>
<NDC>
<NDCCode>50090-2326-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-2326-0) </PackageDescription>
<NDC11Code>50090-2326-00</NDC11Code>
<ProductNDC>50090-2326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-lo-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076784</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)‑ (+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active gray tablet contains 0.18 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, black iron oxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 2 Each active light blue tablet contains 0.215 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 4 Each white tablet contains only inert ingredients, as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>50090-2429-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-2429-0) </PackageDescription>
<NDC11Code>50090-2429-00</NDC11Code>
<ProductNDC>50090-2429</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-lo-marzia</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200541</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Lo-Marzia is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Tri-Lo-Marzia is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as ((+)-13-Ethyl-17-hydroxy-18, 19-dinor-17a-pregn-4-en-20-yn-3-one oxime acetate (ester)) and ethinyl estradiol is designated as (19-nor-17a-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white film-coated tablet contains 0.18 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 2 Each active light blue film-coated tablet contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 3 Each active blue film-coated tablet contains 0.25 mg norgestimate and 0.025 mg ethinyl estradiol. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide., 4 Each green film-coated tablet contains only inert ingredients, as follows: croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-2603-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-2603-0) </PackageDescription>
<NDC11Code>50090-2603-00</NDC11Code>
<ProductNDC>50090-2603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norgestimate And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200494</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norgestimate and ethinyl estradiol tablets are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1). Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg: 1 Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, FD&C Blue No. 2, colloidal silicon dioxide, talc, magnesium stearate, and pregelatinized starch., 2 Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc.</Description>
</NDC>
<NDC>
<NDCCode>50090-3239-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-3239-0) </PackageDescription>
<NDC11Code>50090-3239-00</NDC11Code>
<ProductNDC>50090-3239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri Femynor</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203870</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri Femynor is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1). Tri Femynor is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive birth control. (1.2).</IndicationAndUsage>
<Description>Tri Femynor (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each light pink “active” tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 2 Each light red “active” tablet contains 0.215 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 3 Each red “active” tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 4 Each white placebo tablet contains only inert ingredients, as follows: hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-3413-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-3413-0) </PackageDescription>
<NDC11Code>50090-3413-00</NDC11Code>
<ProductNDC>50090-3413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri Femynor</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203870</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri Femynor is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1). Tri Femynor is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive birth control. (1.2).</IndicationAndUsage>
<Description>Tri Femynor (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each light pink “active” tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 2 Each light red “active” tablet contains 0.215 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 3 Each red “active” tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide., 4 Each white placebo tablet contains only inert ingredients, as follows: hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-3733-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-3733-0) </PackageDescription>
<NDC11Code>50090-3733-00</NDC11Code>
<ProductNDC>50090-3733</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norgestimate And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204057</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norgestimate and ethinyl estradiol tablets are an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Norgestimate and Ethinyl Estradiol Tablets USP are a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white to off-white tablet contains 0.18 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K-30, polyethylene glycol, polusorbate 80, talc, titanium dioxide and vitamin E., 2 Each active light blue tablet contains 0.215 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, FD & C blue #2, FD & C blue #1, FD & C red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K-30, polyethylene glycol, polusorbate 80, talc, titanium dioxide and vitamin E., 3 Each active blue tablet contains 0.25 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, FD & C Blue #2, FD & C blue #1, FD & C red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K-30, polyethylene glycol, polysorbate 80, talc, titanium dioxide and vitamin E., 4 Each green to dark green placebo tablet contains only inert ingredients, as follows: anhydrous lactose, FD&C Blue #2, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrilin potassium, polyethylene glycol, polysorbate 80, talc, and titanium dioxide., 5 .</Description>
</NDC>
<NDC>
<NDCCode>50090-4203-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-4203-0) </PackageDescription>
<NDC11Code>50090-4203-00</NDC11Code>
<ProductNDC>50090-4203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090058</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, talc, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, talc, iron oxide red, yellow iron oxide, and FD&C yellow #6 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol, talc and black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>50090-4434-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-4434-0) </PackageDescription>
<NDC11Code>50090-4434-00</NDC11Code>
<ProductNDC>50090-4434</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200022</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg of memantine hydrochloride and as capsule-shaped, film-coated tablets containing 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, povidone, crospovidone and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coating: hypromellose, titanium dioxide and polyethylene glycol 4000.</Description>
</NDC>
<NDC>
<NDCCode>50090-4877-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-4877-0) </PackageDescription>
<NDC11Code>50090-4877-00</NDC11Code>
<ProductNDC>50090-4877</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207236</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a white, crystalline powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: Microcrystalline Cellulose, NF, Dibasic Calcium Phosphate Anhydrous, USP, Croscarmellose Sodium, NF, Colloidal Silicon Dioxide, NF, Magnesium Stearate, NF. In addition the following inactive ingredients are also present as components of the film coat: Hypromellose 2910 NF, Titanium Dioxide, NF, Polyethylene Glycol, NF, FD&C Yellow 6 Aluminum Lake, FD&C Blue 2 Aluminum Lake (5 mg tablets), and Hypromellose 2910 NF, Titanium Dioxide, Triacetin, NF, Black Iron Oxide, NF, Yellow Iron Oxide, NF, Red Iron Oxide, NF (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>50090-5832-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5832-0) </PackageDescription>
<NDC11Code>50090-5832-00</NDC11Code>
<ProductNDC>50090-5832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202840</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>50090-5926-0</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50090-5926-0) </PackageDescription>
<NDC11Code>50090-5926-00</NDC11Code>
<ProductNDC>50090-5926</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200022</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg of memantine hydrochloride and as capsule-shaped, film-coated tablets containing 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, povidone, crospovidone and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coating: hypromellose, titanium dioxide and polyethylene glycol 4000.</Description>
</NDC>
<NDC>
<NDCCode>50090-6291-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-6291-0) </PackageDescription>
<NDC11Code>50090-6291-00</NDC11Code>
<ProductNDC>50090-6291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090961</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP is a white crystalline powder, soluble in water and in methanol, practically insoluble in acetone. Each memantine hydrochloride tablet, USP intended for oral administration contains 5 mg or 10 mg of memantine hydrochloride. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-6400-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-6400-0) </PackageDescription>
<NDC11Code>50090-6400-00</NDC11Code>
<ProductNDC>50090-6400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206528</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a fine white to off-white powder and is soluble in water.Memantine Tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, talc and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc, FD & C yellow #6/sunset yellow FCF aluminum lake (5 mg tablets), and polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc and iron oxide black (10 mg tablets). USP Assay test pending.</Description>
</NDC>
<NDC>
<NDCCode>50090-7348-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-7348-0) </PackageDescription>
<NDC11Code>50090-7348-00</NDC11Code>
<ProductNDC>50090-7348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204389</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride tablets, USP are an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21N.HCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white powder and is freely soluble in methanol, soluble in water and sparingly soluble in dimethylformamide. Memantine hydrochloride tablets USP are available for oral administration as modified capsule shaped, film coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, isopropyl alcohol, lactose monohydrate, magnesium stearate, povidone and talc. The 5 mg tablets are coated with Opadry Orange which contains FD & C blue # 2, FD & C yellow # 6, hypromellose, polyethylene glycol and titanium dioxide, 10 mg tablets are coated with Opadry Grey which contains hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.</Description>
</NDC>
</NDCList>