{
"NDC": [
{
"NDCCode": "50383-312-84",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-312-84) > 250 mL in 1 BOTTLE",
"NDC11Code": "50383-0312-84",
"ProductNDC": "50383-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211420",
"LabelerName": "Akorn",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-10-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210707",
"SamplePackage": "N"
},
{
"NDCCode": "68462-312-84",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (68462-312-84) > 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "68462-0312-84",
"ProductNDC": "68462-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209663",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N"
},
{
"NDCCode": "0093-3134-82",
"PackageDescription": "2 POUCH in 1 CARTON (0093-3134-82) / 1 BLISTER PACK in 1 POUCH (0093-3134-91) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00093-3134-82",
"ProductNDC": "0093-3134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Camrese",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20110728",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021840",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110728",
"SamplePackage": "N",
"IndicationAndUsage": "CAMRESE® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "CAMRESE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "0093-6148-82",
"PackageDescription": "2 POUCH in 1 CARTON (0093-6148-82) / 1 BLISTER PACK in 1 POUCH (0093-6148-91) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00093-6148-82",
"ProductNDC": "0093-6148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Camrese Lo",
"NonProprietaryName": "Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20111207",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022262",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111207",
"SamplePackage": "N",
"IndicationAndUsage": "CAMRESE LO® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "CAMRESE LO (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "0555-9045-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9045-58",
"ProductNDC": "0555-9045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aviane",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20010402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075796",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2024-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010402",
"SamplePackage": "N",
"IndicationAndUsage": "Aviane (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Aviane (levonorgestrel and ethinyl estradiol tablets) in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with Aviane (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. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. 7 light-green, inert tablets each containing: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Levonorgestrel, USP. C21H28O2 M.W. 312.45. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0555-9123-66",
"PackageDescription": "3 POUCH in 1 CARTON (0555-9123-66) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9123-66",
"ProductNDC": "0555-9123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jolessa",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20031013",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021544",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20031013",
"SamplePackage": "N",
"IndicationAndUsage": "JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF."
},
{
"NDCCode": "31722-944-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (31722-944-32) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "31722-0944-32",
"ProductNDC": "31722-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgetsrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgetsrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20230213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212298",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2023-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230213",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and Ethinyl Estradiol tablets 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 2 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. TABLE 2: Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel 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 proportion of women who become 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 proportion 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 dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. 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": "21 white active tablets each containing 0.1 mg of levonorgestrel USP, (17α)-(-)-13-ethyl-17-hydroxy-18,19, dinorpregna-4-en-20-yn-3-one, and 0.02 mg of ethinyl estradiol USP, 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17β-diol. The inactive ingredients present are cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone. 7 orange inert tablets, each containing cellulose microcrystalline, colloidal silicon dioxide, FD&C Red#40, FD&C Yellow#6, iron oxide yellow, lactose monohydrate, magnesium stearate. Levonorgestrel C 21H 28O 2 M.W. 312.5 Ethinyl Estradiol C 20H 24O 2 M.W. 296.41."
},
{
"NDCCode": "43419-312-06",
"PackageDescription": "14 g in 1 CONTAINER (43419-312-06)",
"NDC11Code": "43419-0312-06",
"ProductNDC": "43419-312",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iope Retigen Moisture Twin Cake No.23",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".84; .868; .4116",
"StrengthUnit": "g/14g; g/14g; g/14g",
"Status": "Deprecated",
"LastUpdate": "2018-10-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50090-2097-0",
"PackageDescription": "1 KIT in 1 KIT (50090-2097-0) ",
"NDC11Code": "50090-2097-00",
"ProductNDC": "50090-2097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ashlyna",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20150223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203163",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151012",
"SamplePackage": "N",
"IndicationAndUsage": "Ashlynais indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) is an extended-cycle oral contraceptive consisting of 84 light blue to blue tablets each containing 0.15 mg of levonorgestrel, USP a synthetic progestogen and 0.03 mg of ethinyl estradiol, USP and 7 light yellow to yellow tablets containing 0.01 mg of ethinyl estradiol, USP. The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue to blue tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Each light yellow to yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 400, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "51285-087-87",
"PackageDescription": "2 POUCH in 1 CARTON (51285-087-87) / 1 BLISTER PACK in 1 POUCH (51285-087-82) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0087-87",
"ProductNDC": "51285-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seasonique",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20060710",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021840",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060710",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "SEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "SEASONIQUE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "51285-092-87",
"PackageDescription": "2 POUCH in 1 CARTON (51285-092-87) / 1 BLISTER PACK in 1 POUCH (51285-092-82) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0092-87",
"ProductNDC": "51285-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loseasonique",
"NonProprietaryName": "Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20090323",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022262",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090323",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "LOSEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "LOSEASONIQUE (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "53002-1779-1",
"PackageDescription": "1 KIT in 1 BLISTER PACK (53002-1779-1) ",
"NDC11Code": "53002-1779-01",
"ProductNDC": "53002-1779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jolessa",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20031013",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021544",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF."
},
{
"NDCCode": "53002-1779-3",
"PackageDescription": "3 BLISTER PACK in 1 POUCH (53002-1779-3) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "53002-1779-03",
"ProductNDC": "53002-1779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jolessa",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20031013",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021544",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF."
},
{
"NDCCode": "53002-1779-6",
"PackageDescription": "6 BLISTER PACK in 1 POUCH (53002-1779-6) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "53002-1779-06",
"ProductNDC": "53002-1779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jolessa",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20031013",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021544",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF."
},
{
"NDCCode": "54868-6210-0",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-6210-0) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "54868-6210-00",
"ProductNDC": "54868-6210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lutera",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20101213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076625",
"LabelerName": "Physicians Total Care, Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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 Lutera, 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. C21H28O2 M.W. 312.45 C20H24O2 M.W. 296.4."
},
{
"NDCCode": "57297-848-13",
"PackageDescription": "2 POUCH in 1 CARTON (57297-848-13) > 1 BLISTER PACK in 1 POUCH (57297-848-11) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "57297-0848-13",
"ProductNDC": "57297-848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20111202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091674",
"LabelerName": "LUPIN LIMITED",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1).",
"Description": "Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP provide an oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 mustard tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are:. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets include croscarmellose sodium, FD&C yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. Inactive ingredients for the mustard tablets include FD&C Yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. Ethinyl Estradiol Tablets USP, 0.01 mg meets USP Dissolution Test 2."
},
{
"NDCCode": "68180-848-13",
"PackageDescription": "2 POUCH in 1 CARTON (68180-848-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "68180-0848-13",
"ProductNDC": "68180-848",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20111202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091674",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111202",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.(1).",
"Description": "Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 mustard tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are:. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets include croscarmellose sodium, FD&C yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. Inactive ingredients for the mustard tablets include FD&C Yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. Ethinyl Estradiol Tablets, USP, 0.01 mg meets USP Dissolution Test 2."
},
{
"NDCCode": "68462-388-29",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84) ",
"NDC11Code": "68462-0388-29",
"ProductNDC": "68462-388",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marlissa",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20120229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091452",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120229",
"SamplePackage": "N",
"IndicationAndUsage": "MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 light orange to orange color MARLISSA® (levonorgestrel and ethinyl estradiol tablets), each containing 0.15 mg of levonorgestrel, USP, a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, an estrogen and 7 light pink to pink inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically d(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each light orange to orange color active tablet contains the following inactive ingredients: FD&C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. In addition, the film-coating contains hypromellose and macrogol. Each light pink to pink inert tablet contains the following inactive ingredients: D&C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc."
},
{
"NDCCode": "68462-646-93",
"PackageDescription": "2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91) ",
"NDC11Code": "68462-0646-93",
"ProductNDC": "68462-646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ashlyna",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20150223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203163",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150223",
"SamplePackage": "N",
"IndicationAndUsage": "Ashlynais indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) is an extended-cycle oral contraceptive consisting of 84 light blue to blue tablets each containing 0.15 mg of levonorgestrel, USP a synthetic progestogen and 0.03 mg of ethinyl estradiol, USP and 7 light yellow to yellow tablets containing 0.01 mg of ethinyl estradiol, USP. The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue to blue tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Each light yellow to yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 400, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "68462-672-95",
"PackageDescription": "3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "68462-0672-95",
"ProductNDC": "68462-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20150612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203164",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150612",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Levonorgestrel and Ethinyl Estradiol Tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 light blue to blue active tablets each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 0.03 mg of ethinyl estradiol, USP, an estrogen, and 7 white to off-white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.45. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each light blue to blue active tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake. , 2 Each white to off-white inert tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate."
},
{
"NDCCode": "70700-117-87",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (70700-117-87) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0117-87",
"ProductNDC": "70700-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Introvale",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079064",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Introvale® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Introvale (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 peach active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel C21H28O2 MW:312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol C20H24O2 MW:296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each peach active tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, iron oxide yellow, iron oxide red and iron oxide black., 2 Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "70700-123-87",
"PackageDescription": "1 BLISTER PACK in 1 BOX (70700-123-87) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0123-87",
"ProductNDC": "70700-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jaimiess",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203770",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Jaimiess is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Jaimiess (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets, USP) is an extended-cycle oral contraceptive consisting of 84 peach tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each peach tablet contains the following inactive ingredients: anhydrous lactose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, povidone, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each yellow tablet contains the following inactive ingredients: iron oxide yellow, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "70700-124-87",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (70700-124-87) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0124-87",
"ProductNDC": "70700-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lojaimiess",
"NonProprietaryName": "Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205131",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N",
"IndicationAndUsage": "LoJaimiess is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "LoJaimiess (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) tablets provide an oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets include anhydrous lactose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, red iron oxide, talc, titanium dioxide, and yellow iron oxide. Inactive ingredients for the yellow tablets include lecithin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, yellow iron oxide and xanthan gum."
},
{
"NDCCode": "50383-001-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-001-02) > 60 mL in 1 BOTTLE",
"NDC11Code": "50383-0001-02",
"ProductNDC": "50383-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074731",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
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"LabelerName": "Akorn",
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
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<Pharm_Classes>Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]</Pharm_Classes>
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<PackageDescription>2 POUCH in 1 CARTON (0093-3134-82) / 1 BLISTER PACK in 1 POUCH (0093-3134-91) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00093-3134-82</NDC11Code>
<ProductNDC>0093-3134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Camrese</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110728</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021840</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>CAMRESE® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>CAMRESE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0093-6148-82</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (0093-6148-82) / 1 BLISTER PACK in 1 POUCH (0093-6148-91) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00093-6148-82</NDC11Code>
<ProductNDC>0093-6148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Camrese Lo</ProprietaryName>
<NonProprietaryName>Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20111207</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022262</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAMRESE LO® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>CAMRESE LO (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0555-9045-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9045-58</NDC11Code>
<ProductNDC>0555-9045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aviane</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20010402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075796</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aviane (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Aviane (levonorgestrel and ethinyl estradiol tablets) in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with Aviane (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. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. 7 light-green, inert tablets each containing: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Levonorgestrel, USP. C21H28O2 M.W. 312.45. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0555-9123-66</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (0555-9123-66) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9123-66</NDC11Code>
<ProductNDC>0555-9123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jolessa</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20031013</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021544</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>31722-944-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (31722-944-32) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0944-32</NDC11Code>
<ProductNDC>31722-944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgetsrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgetsrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212298</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and Ethinyl Estradiol tablets 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 2 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. TABLE 2: Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel 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 proportion of women who become 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 proportion 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 dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. 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>21 white active tablets each containing 0.1 mg of levonorgestrel USP, (17α)-(-)-13-ethyl-17-hydroxy-18,19, dinorpregna-4-en-20-yn-3-one, and 0.02 mg of ethinyl estradiol USP, 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17β-diol. The inactive ingredients present are cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone. 7 orange inert tablets, each containing cellulose microcrystalline, colloidal silicon dioxide, FD&C Red#40, FD&C Yellow#6, iron oxide yellow, lactose monohydrate, magnesium stearate. Levonorgestrel C 21H 28O 2 M.W. 312.5 Ethinyl Estradiol C 20H 24O 2 M.W. 296.41.</Description>
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<NDCCode>43419-312-06</NDCCode>
<PackageDescription>14 g in 1 CONTAINER (43419-312-06)</PackageDescription>
<NDC11Code>43419-0312-06</NDC11Code>
<ProductNDC>43419-312</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iope Retigen Moisture Twin Cake No.23</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.84; .868; .4116</StrengthNumber>
<StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-2097-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-2097-0) </PackageDescription>
<NDC11Code>50090-2097-00</NDC11Code>
<ProductNDC>50090-2097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ashlyna</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203163</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ashlynais indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) is an extended-cycle oral contraceptive consisting of 84 light blue to blue tablets each containing 0.15 mg of levonorgestrel, USP a synthetic progestogen and 0.03 mg of ethinyl estradiol, USP and 7 light yellow to yellow tablets containing 0.01 mg of ethinyl estradiol, USP. The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue to blue tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Each light yellow to yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 400, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-087-87</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (51285-087-87) / 1 BLISTER PACK in 1 POUCH (51285-087-82) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0087-87</NDC11Code>
<ProductNDC>51285-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Seasonique</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060710</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021840</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060710</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>SEASONIQUE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-092-87</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (51285-092-87) / 1 BLISTER PACK in 1 POUCH (51285-092-82) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0092-87</NDC11Code>
<ProductNDC>51285-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loseasonique</ProprietaryName>
<NonProprietaryName>Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090323</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022262</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090323</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOSEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>LOSEASONIQUE (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53002-1779-1</NDCCode>
<PackageDescription>1 KIT in 1 BLISTER PACK (53002-1779-1) </PackageDescription>
<NDC11Code>53002-1779-01</NDC11Code>
<ProductNDC>53002-1779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jolessa</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20031013</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021544</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>53002-1779-3</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 POUCH (53002-1779-3) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1779-03</NDC11Code>
<ProductNDC>53002-1779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jolessa</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20031013</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021544</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>53002-1779-6</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 POUCH (53002-1779-6) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1779-06</NDC11Code>
<ProductNDC>53002-1779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jolessa</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20031013</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021544</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JOLESSA® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. , 2 Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>54868-6210-0</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (54868-6210-0) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-6210-00</NDC11Code>
<ProductNDC>54868-6210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lutera</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20101213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076625</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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 Lutera, 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. C21H28O2 M.W. 312.45 C20H24O2 M.W. 296.4.</Description>
</NDC>
<NDC>
<NDCCode>57297-848-13</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (57297-848-13) > 1 BLISTER PACK in 1 POUCH (57297-848-11) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57297-0848-13</NDC11Code>
<ProductNDC>57297-848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20111202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091674</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1).</IndicationAndUsage>
<Description>Levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP provide an oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 mustard tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are:. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets include croscarmellose sodium, FD&C yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. Inactive ingredients for the mustard tablets include FD&C Yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. Ethinyl Estradiol Tablets USP, 0.01 mg meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68180-848-13</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (68180-848-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68180-0848-13</NDC11Code>
<ProductNDC>68180-848</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20111202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091674</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.(1).</IndicationAndUsage>
<Description>Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 mustard tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are:. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets include croscarmellose sodium, FD&C yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol and titanium dioxide. Inactive ingredients for the mustard tablets include FD&C Yellow # 6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. Ethinyl Estradiol Tablets, USP, 0.01 mg meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68462-388-29</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84) </PackageDescription>
<NDC11Code>68462-0388-29</NDC11Code>
<ProductNDC>68462-388</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marlissa</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091452</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 light orange to orange color MARLISSA® (levonorgestrel and ethinyl estradiol tablets), each containing 0.15 mg of levonorgestrel, USP, a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, an estrogen and 7 light pink to pink inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically d(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each light orange to orange color active tablet contains the following inactive ingredients: FD&C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. In addition, the film-coating contains hypromellose and macrogol. Each light pink to pink inert tablet contains the following inactive ingredients: D&C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc.</Description>
</NDC>
<NDC>
<NDCCode>68462-646-93</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91) </PackageDescription>
<NDC11Code>68462-0646-93</NDC11Code>
<ProductNDC>68462-646</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ashlyna</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203163</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ashlynais indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) is an extended-cycle oral contraceptive consisting of 84 light blue to blue tablets each containing 0.15 mg of levonorgestrel, USP a synthetic progestogen and 0.03 mg of ethinyl estradiol, USP and 7 light yellow to yellow tablets containing 0.01 mg of ethinyl estradiol, USP. The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.4. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue to blue tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Each light yellow to yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 400, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-672-95</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0672-95</NDC11Code>
<ProductNDC>68462-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203164</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Levonorgestrel and Ethinyl Estradiol Tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 light blue to blue active tablets each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 0.03 mg of ethinyl estradiol, USP, an estrogen, and 7 white to off-white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel, USP. C21H28O2 MW: 312.45. Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol, USP. C20H24O2 MW: 296.4. Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each light blue to blue active tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake. , 2 Each white to off-white inert tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70700-117-87</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (70700-117-87) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0117-87</NDC11Code>
<ProductNDC>70700-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Introvale</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079064</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Introvale® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Introvale (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 peach active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel C21H28O2 MW:312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol C20H24O2 MW:296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : 1 Each peach active tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, iron oxide yellow, iron oxide red and iron oxide black., 2 Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70700-123-87</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (70700-123-87) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0123-87</NDC11Code>
<ProductNDC>70700-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jaimiess</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203770</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Jaimiess is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Jaimiess (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets, USP) is an extended-cycle oral contraceptive consisting of 84 peach tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each peach tablet contains the following inactive ingredients: anhydrous lactose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, povidone, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each yellow tablet contains the following inactive ingredients: iron oxide yellow, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>70700-124-87</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (70700-124-87) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0124-87</NDC11Code>
<ProductNDC>70700-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lojaimiess</ProprietaryName>
<NonProprietaryName>Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205131</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LoJaimiess is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>LoJaimiess (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) tablets provide an oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets include anhydrous lactose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, red iron oxide, talc, titanium dioxide, and yellow iron oxide. Inactive ingredients for the yellow tablets include lecithin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, yellow iron oxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>50383-001-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-001-02) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0001-02</NDC11Code>
<ProductNDC>50383-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074731</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-001-20</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-001-20) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0001-20</NDC11Code>
<ProductNDC>50383-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074731</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-010-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-010-15) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0010-15</NDC11Code>
<ProductNDC>50383-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Redness Reliever</ProprietaryName>
<NonProprietaryName>Redness Reliever</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960617</StartMarketingDate>
<EndMarketingDate>20140420</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>50383-018-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-018-04) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0018-04</NDC11Code>
<ProductNDC>50383-018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eye Wash</ProprietaryName>
<NonProprietaryName>Eye Wash</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>INTRAOCULAR</RouteName>
<StartMarketingDate>19970106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>980</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-021-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-021-05) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0021-05</NDC11Code>
<ProductNDC>50383-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20020910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075163</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-021-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-021-10) > 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0021-10</NDC11Code>
<ProductNDC>50383-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20020910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075163</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-021-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-021-15) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0021-15</NDC11Code>
<ProductNDC>50383-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20020910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075163</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>