{
"NDC": [
{
"NDCCode": "51862-449-18",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (51862-449-18) ",
"NDC11Code": "51862-0449-18",
"ProductNDC": "51862-449",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070929",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160718",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "51862-447-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (51862-447-18) ",
"NDC11Code": "51862-0447-18",
"ProductNDC": "51862-447",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075797",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160803",
"EndMarketingDatePackage": "20210531",
"SamplePackage": "N"
},
{
"NDCCode": "51862-449-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (51862-449-60) ",
"NDC11Code": "51862-0449-60",
"ProductNDC": "51862-449",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070929",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160718",
"EndMarketingDatePackage": "20190228",
"SamplePackage": "N"
},
{
"NDCCode": "63824-449-10",
"PackageDescription": "1 KIT in 1 CARTON (63824-449-10) * 90 CLOTH in 1 JAR (63824-431-90) * 18 PATCH in 1 POUCH * 200 mL in 1 TUBE (63824-432-01) ",
"NDC11Code": "63824-0449-10",
"ProductNDC": "63824-449",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clearasil Rapidly Clear Acne Solutions",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "KIT",
"StartMarketingDate": "20200901",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "RB Health (US) LLC",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200901",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N"
},
{
"NDCCode": "51862-028-06",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-028-06) / 1 KIT in 1 BLISTER PACK (51862-028-01) ",
"NDC11Code": "51862-0028-06",
"ProductNDC": "51862-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lutera",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076625",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160803",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Lutera is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
"Description": "Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d (-)-13β-ethyl-17α-ethinyl-17β- hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl- 1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive, peach tablet (7) contains the following inactive ingredients: FD&C Yellow #6, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "51862-047-91",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51862-047-91) > 1 KIT in 1 BLISTER PACK (51862-047-01) ",
"NDC11Code": "51862-0047-91",
"ProductNDC": "51862-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amethia",
"NonProprietaryName": "Ethinyl Estradiol And Levonorgestrel",
"DosageFormName": "KIT",
"StartMarketingDate": "20161012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078834",
"LabelerName": "Mayne Pharma Inc",
"Status": "Deprecated",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161012",
"SamplePackage": "N",
"IndicationAndUsage": "AMETHIA tablets are indicated for use by women to prevent pregnancy.",
"Description": "AMETHIA tablets are an extended-cycle oral contraceptive consisting of 84 white tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 light blue tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each white tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium and magnesium stearate. Each light blue tablet contains the following inactive ingredients: vitamin E, anhydrous lactose, povidone, FD&C Blue #1, colloidal silicon dioxide, corn starch and stearic acid."
},
{
"NDCCode": "51862-097-06",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-097-06) / 1 KIT in 1 BLISTER PACK (51862-097-01) ",
"NDC11Code": "51862-0097-06",
"ProductNDC": "51862-097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levora",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073594",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160803",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "LEVORA 0.15/30-28 is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "LEVORA ®0.15/30-28 (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 white active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 peach inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α) (-)-. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each white active tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each peach inert tablet contains the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "51862-148-03",
"PackageDescription": "3 POUCH in 1 CARTON (51862-148-03) / 21 d in 1 POUCH (51862-148-01) ",
"NDC11Code": "51862-0148-03",
"ProductNDC": "51862-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloette",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
"DosageFormName": "INSERT, EXTENDED RELEASE",
"RouteName": "VAGINAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211328",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; ETONOGESTREL",
"StrengthNumber": ".015; .12",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "FOR VAGINAL USE ONLY. Haloette® is indicated for use by females of reproductive age to prevent pregnancy.",
"Description": "Haloette (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Haloette is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Haloette is not made with natural rubber latex. Haloette has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows."
},
{
"NDCCode": "51862-158-60",
"PackageDescription": "1 TUBE in 1 CARTON (51862-158-60) > 60 g in 1 TUBE",
"NDC11Code": "51862-0158-60",
"ProductNDC": "51862-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flurandrenolide",
"NonProprietaryName": "Flurandrenolide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207851",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "FLURANDRENOLIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N"
},
{
"NDCCode": "51862-514-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (51862-514-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-01",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51862-514-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-514-02) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-02",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51862-514-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (51862-514-03) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-03",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51862-514-06",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-514-06) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0514-06",
"ProductNDC": "51862-514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desogestrel And Ethinyl Estradiol",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091234",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201004",
"SamplePackage": "N",
"IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
"Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51862-560-00",
"PackageDescription": "1 BOTTLE in 1 CARTON (51862-560-00) / 6 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "51862-0560-00",
"ProductNDC": "51862-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx Mpc",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230102",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections ( 1.1) , 2 Sexually Transmitted Infections ( 1.2) , 3 Respiratory Tract Infections( 1.3) , 4 Specific Bacterial Infections ( 1.4) , 5 Ophthalmic Infections ( 1.5) , 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) ( 1.6) , 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated ( 1.7) , 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne ( 1.8) , 9 Prophylaxis of Malaria ( 1.9) .",
"Description": "Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium."
},
{
"NDCCode": "51862-560-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-560-12) ",
"NDC11Code": "51862-0560-12",
"ProductNDC": "51862-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx Mpc",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230102",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections (1.1), 2 Sexually Transmitted Infections (1.2), 3 Respiratory Tract Infections(1.3), 4 Specific Bacterial Infections (1.4), 5 Ophthalmic Infections (1.5), 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) (1.6), 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated (1.7), 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne (1.8), 9 Prophylaxis of Malaria (1.9).",
"Description": "Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium."
},
{
"NDCCode": "51862-560-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-560-60) ",
"NDC11Code": "51862-0560-60",
"ProductNDC": "51862-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx Mpc",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240513",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections ( 1.1) , 2 Sexually Transmitted Infections ( 1.2) , 3 Respiratory Tract Infections( 1.3) , 4 Specific Bacterial Infections ( 1.4) , 5 Ophthalmic Infections ( 1.5) , 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) ( 1.6) , 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated ( 1.7) , 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne ( 1.8) , 9 Prophylaxis of Malaria ( 1.9) .",
"Description": "Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium."
},
{
"NDCCode": "51862-564-06",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01) ",
"NDC11Code": "51862-0564-06",
"ProductNDC": "51862-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Low-ogestrel",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160803",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075288",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160803",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets."
},
{
"NDCCode": "51862-571-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-571-30) ",
"NDC11Code": "51862-0571-30",
"ProductNDC": "51862-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201002",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201002",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).",
"Description": "Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium."
},
{
"NDCCode": "51862-634-28",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (51862-634-28) / 1 TABLET in 1 BLISTER PACK (51862-634-01) ",
"NDC11Code": "51862-0634-28",
"ProductNDC": "51862-634",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Buccal",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "TABLET",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190614",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021947",
"LabelerName": "Mayne Pharma",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190614",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.",
"Description": "Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate."
},
{
"NDCCode": "51862-635-28",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (51862-635-28) / 1 TABLET in 1 BLISTER PACK (51862-635-01) ",
"NDC11Code": "51862-0635-28",
"ProductNDC": "51862-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Buccal",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "TABLET",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190614",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021947",
"LabelerName": "Mayne Pharma",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190614",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.",
"Description": "Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate."
},
{
"NDCCode": "51862-636-28",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (51862-636-28) / 1 TABLET in 1 BLISTER PACK (51862-636-01) ",
"NDC11Code": "51862-0636-28",
"ProductNDC": "51862-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Buccal",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "TABLET",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190614",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021947",
"LabelerName": "Mayne Pharma",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190614",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.",
"Description": "Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate."
},
{
"NDCCode": "51862-637-28",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (51862-637-28) / 1 TABLET in 1 BLISTER PACK (51862-637-01) ",
"NDC11Code": "51862-0637-28",
"ProductNDC": "51862-637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Buccal",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "TABLET",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190614",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021947",
"LabelerName": "Mayne Pharma",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190614",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.",
"Description": "Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate."
},
{
"NDCCode": "51862-638-28",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (51862-638-28) / 1 TABLET in 1 BLISTER PACK (51862-638-01) ",
"NDC11Code": "51862-0638-28",
"ProductNDC": "51862-638",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Buccal",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "TABLET",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190614",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021947",
"LabelerName": "Mayne Pharma",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "800",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190614",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.",
"Description": "Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate."
},
{
"NDCCode": "51862-645-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (51862-645-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0645-01",
"ProductNDC": "51862-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nymyo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090523",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201011",
"SamplePackage": "N",
"IndicationAndUsage": "Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "51862-645-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-645-02) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0645-02",
"ProductNDC": "51862-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nymyo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090523",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201011",
"SamplePackage": "N",
"IndicationAndUsage": "Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "51862-645-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (51862-645-03) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0645-03",
"ProductNDC": "51862-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nymyo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090523",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201011",
"SamplePackage": "N",
"IndicationAndUsage": "Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "51862-645-06",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-645-06) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0645-06",
"ProductNDC": "51862-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nymyo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090523",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201011",
"SamplePackage": "N",
"IndicationAndUsage": "Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "51862-646-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (51862-646-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0646-01",
"ProductNDC": "51862-646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-nymyo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090524",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201024",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1). Tri-Nymyo 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-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 4 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "51862-646-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-646-02) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0646-02",
"ProductNDC": "51862-646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-nymyo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090524",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201024",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1). Tri-Nymyo 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-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 4 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "51862-646-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (51862-646-03) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0646-03",
"ProductNDC": "51862-646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-nymyo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090524",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2022-12-09",
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"IndicationAndUsage": "Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1). Tri-Nymyo 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-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 4 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
}
]
}
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<Status>Deprecated</Status>
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<StartMarketingDatePackage>20160718</StartMarketingDatePackage>
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<PackageDescription>1 KIT in 1 CARTON (63824-449-10) * 90 CLOTH in 1 JAR (63824-431-90) * 18 PATCH in 1 POUCH * 200 mL in 1 TUBE (63824-432-01) </PackageDescription>
<NDC11Code>63824-0449-10</NDC11Code>
<ProductNDC>63824-449</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clearasil Rapidly Clear Acne Solutions</ProprietaryName>
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<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>RB Health (US) LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<PackageDescription>6 BLISTER PACK in 1 CARTON (51862-028-06) / 1 KIT in 1 BLISTER PACK (51862-028-01) </PackageDescription>
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<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076625</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lutera is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d (-)-13β-ethyl-17α-ethinyl-17β- hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl- 1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive, peach tablet (7) contains the following inactive ingredients: FD&C Yellow #6, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.</Description>
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<NDC>
<NDCCode>51862-047-91</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (51862-047-91) > 1 KIT in 1 BLISTER PACK (51862-047-01) </PackageDescription>
<NDC11Code>51862-0047-91</NDC11Code>
<ProductNDC>51862-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amethia</ProprietaryName>
<NonProprietaryName>Ethinyl Estradiol And Levonorgestrel</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078834</ApplicationNumber>
<LabelerName>Mayne Pharma Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMETHIA tablets are indicated for use by women to prevent pregnancy.</IndicationAndUsage>
<Description>AMETHIA tablets are an extended-cycle oral contraceptive consisting of 84 white tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 light blue tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each white tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium and magnesium stearate. Each light blue tablet contains the following inactive ingredients: vitamin E, anhydrous lactose, povidone, FD&C Blue #1, colloidal silicon dioxide, corn starch and stearic acid.</Description>
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<NDC>
<NDCCode>51862-097-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (51862-097-06) / 1 KIT in 1 BLISTER PACK (51862-097-01) </PackageDescription>
<NDC11Code>51862-0097-06</NDC11Code>
<ProductNDC>51862-097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levora</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073594</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160803</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LEVORA 0.15/30-28 is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>LEVORA ®0.15/30-28 (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 white active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 peach inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α) (-)-. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each white active tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each peach inert tablet contains the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>51862-148-03</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (51862-148-03) / 21 d in 1 POUCH (51862-148-01) </PackageDescription>
<NDC11Code>51862-0148-03</NDC11Code>
<ProductNDC>51862-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloette</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>INSERT, EXTENDED RELEASE</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211328</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; ETONOGESTREL</SubstanceName>
<StrengthNumber>.015; .12</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR VAGINAL USE ONLY. Haloette® is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
<Description>Haloette (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Haloette is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Haloette is not made with natural rubber latex. Haloette has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows.</Description>
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<NDC>
<NDCCode>51862-158-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51862-158-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>51862-0158-60</NDC11Code>
<ProductNDC>51862-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flurandrenolide</ProprietaryName>
<NonProprietaryName>Flurandrenolide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207851</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>FLURANDRENOLIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>51862-514-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (51862-514-01) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0514-01</NDC11Code>
<ProductNDC>51862-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desogestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091234</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51862-514-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51862-514-02) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0514-02</NDC11Code>
<ProductNDC>51862-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desogestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091234</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
</NDC>
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<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each "active" orange tablet with "S3" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each "inactive" reminder white, biconvex, round tablets with "P" debossed on one side and "N" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2.</Description>
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<IndicationAndUsage>DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections ( 1.1) , 2 Sexually Transmitted Infections ( 1.2) , 3 Respiratory Tract Infections( 1.3) , 4 Specific Bacterial Infections ( 1.4) , 5 Ophthalmic Infections ( 1.5) , 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) ( 1.6) , 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated ( 1.7) , 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne ( 1.8) , 9 Prophylaxis of Malaria ( 1.9) .</IndicationAndUsage>
<Description>Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium.</Description>
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<IndicationAndUsage>DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections (1.1), 2 Sexually Transmitted Infections (1.2), 3 Respiratory Tract Infections(1.3), 4 Specific Bacterial Infections (1.4), 5 Ophthalmic Infections (1.5), 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) (1.6), 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated (1.7), 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne (1.8), 9 Prophylaxis of Malaria (1.9).</IndicationAndUsage>
<Description>Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium.</Description>
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<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
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<IndicationAndUsage>DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections ( 1.1) , 2 Sexually Transmitted Infections ( 1.2) , 3 Respiratory Tract Infections( 1.3) , 4 Specific Bacterial Infections ( 1.4) , 5 Ophthalmic Infections ( 1.5) , 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) ( 1.6) , 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated ( 1.7) , 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne ( 1.8) , 9 Prophylaxis of Malaria ( 1.9) .</IndicationAndUsage>
<Description>Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium.</Description>
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<NDC11Code>51862-0564-06</NDC11Code>
<ProductNDC>51862-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Low-ogestrel</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160803</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075288</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160803</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets.</Description>
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<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-571-30) </PackageDescription>
<NDC11Code>51862-0571-30</NDC11Code>
<ProductNDC>51862-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201002</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6- methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg, 75 mg, 80 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 57.7 mg, 86.6 mg, 92.3 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each doxycycline hyclate delayed-release tablets 50 mg tablet contains 3 mg (0.131 mEq) of sodium, each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.5 mg (0.196 mEq) of sodium, each doxycycline hyclate delayed-release tablets 80 mg tablet contains 4.8 mg (0.209 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6 mg (0.261 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9 mg (0.392 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12 mg (0.522 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>51862-634-28</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (51862-634-28) / 1 TABLET in 1 BLISTER PACK (51862-634-01) </PackageDescription>
<NDC11Code>51862-0634-28</NDC11Code>
<ProductNDC>51862-634</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Buccal</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021947</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.</IndicationAndUsage>
<Description>Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>51862-635-28</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (51862-635-28) / 1 TABLET in 1 BLISTER PACK (51862-635-01) </PackageDescription>
<NDC11Code>51862-0635-28</NDC11Code>
<ProductNDC>51862-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Buccal</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021947</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.</IndicationAndUsage>
<Description>Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>51862-636-28</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (51862-636-28) / 1 TABLET in 1 BLISTER PACK (51862-636-01) </PackageDescription>
<NDC11Code>51862-0636-28</NDC11Code>
<ProductNDC>51862-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Buccal</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021947</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.</IndicationAndUsage>
<Description>Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>51862-637-28</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (51862-637-28) / 1 TABLET in 1 BLISTER PACK (51862-637-01) </PackageDescription>
<NDC11Code>51862-0637-28</NDC11Code>
<ProductNDC>51862-637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Buccal</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021947</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.</IndicationAndUsage>
<Description>Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>51862-638-28</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (51862-638-28) / 1 TABLET in 1 BLISTER PACK (51862-638-01) </PackageDescription>
<NDC11Code>51862-0638-28</NDC11Code>
<ProductNDC>51862-638</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Buccal</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190614</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021947</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190614</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.</IndicationAndUsage>
<Description>Fentanyl buccal tablet is an opioid agonist, intended for buccal mucosal administration. Fentanyl buccal tablet is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. Fentanyl buccal tablet employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base. Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>51862-645-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (51862-645-01) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0645-01</NDC11Code>
<ProductNDC>51862-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nymyo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090523</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>51862-645-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51862-645-02) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0645-02</NDC11Code>
<ProductNDC>51862-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nymyo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090523</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>51862-645-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (51862-645-03) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0645-03</NDC11Code>
<ProductNDC>51862-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nymyo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090523</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>51862-645-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (51862-645-06) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0645-06</NDC11Code>
<ProductNDC>51862-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nymyo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090523</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>51862-646-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (51862-646-01) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0646-01</NDC11Code>
<ProductNDC>51862-646</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-nymyo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090524</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1). Tri-Nymyo 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-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 4 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>51862-646-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51862-646-02) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0646-02</NDC11Code>
<ProductNDC>51862-646</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-nymyo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090524</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1). Tri-Nymyo 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-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 4 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>51862-646-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (51862-646-03) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0646-03</NDC11Code>
<ProductNDC>51862-646</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-nymyo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090524</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1). Tri-Nymyo 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-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 4 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
</NDCList>