{
"NDC": [
{
"NDCCode": "70700-307-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-307-85) / 1 BLISTER PACK in 1 POUCH (70700-307-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0307-85",
"ProductNDC": "70700-307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feirza 1/20",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol Tablets Usp, 1 Mg/0.02 Mg And Ferrous Fumarate Tablets, 75 Mg",
"DosageFormName": "KIT",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202772",
"LabelerName": "Xiromed LLC",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Feirza 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Feirza 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) is a progestogen-estrogen combination. Feirza 1/20 provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off-white tablet contains norethindrone acetate (19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)), 1 mg; ethinyl estradiol (19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α)-), 20 mcg. Also contains compressible sugar, croscarmellose sodium, dl-α-tocopherol, lactose anhydrous, lactose monohydrate, magnesium stearate, povidone K-25, sodium lauryl sulphate. The structural formulas are as follows. Each brown placebo tablet contains colloidal silicon dioxide, croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-90. The ferrous fumarate tablets do not serve any therapeutic purpose."
},
{
"NDCCode": "43744-307-85",
"PackageDescription": "25000 g in 1 DRUM (43744-307-85)",
"NDC11Code": "43744-0307-85",
"ProductNDC": "43744-307",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dipyrone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "DIPYRONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "59088-307-07",
"PackageDescription": "85 g in 1 BOTTLE (59088-307-07) ",
"NDC11Code": "59088-0307-07",
"ProductNDC": "59088-307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidotral 3.88% Roll On",
"NonProprietaryName": "Lidocaine Hci",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240228",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "38.8",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
"Description": "Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:."
},
{
"NDCCode": "70680-307-00",
"PackageDescription": "85 g in 1 CAN (70680-307-00) ",
"NDC11Code": "70680-0307-00",
"ProductNDC": "70680-307",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Raw Elements Baby Kids Broad Spectrum Spf30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190415",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Raw Elements LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2023-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190415",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "85477-307-85",
"PackageDescription": "85 g in 1 TUBE (85477-307-85) ",
"NDC11Code": "85477-0307-85",
"ProductNDC": "85477-307",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topicaine Ultra",
"NonProprietaryName": "Topicaine Ultra",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Oncora Pharma, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with: 1 minor burns, 2 sunburn, 3 minor cuts, 4 scrapes, 5 insect bites, 6 minor skin irritations."
},
{
"NDCCode": "70700-101-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-101-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0101-85",
"ProductNDC": "70700-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol Tablets And Ferrous Fumarate Tablets",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209609",
"LabelerName": "Xiromed, LLC",
"Status": "Active",
"LastUpdate": "2023-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180824",
"SamplePackage": "N",
"IndicationAndUsage": "Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets, 1 mg/20 mcg provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 1 24 white, round tablets each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol., 2 4 brown, round tablets each containing 75 mg ferrous fumarate."
},
{
"NDCCode": "70700-104-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-104-85) > 1 KIT in 1 BLISTER PACK (70700-104-84) ",
"NDC11Code": "70700-0104-85",
"ProductNDC": "70700-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol Tablets",
"DosageFormName": "KIT",
"StartMarketingDate": "20170808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202507",
"LabelerName": "Xiromed, LLC.",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170808",
"SamplePackage": "N"
},
{
"NDCCode": "70700-113-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-113-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0113-85",
"ProductNDC": "70700-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isibloom",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202789",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "Isibloom (desogestrel 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong 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. cAmong 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. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.",
"Description": "Isibloom (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used."
},
{
"NDCCode": "70700-114-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-114-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0114-85",
"ProductNDC": "70700-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loryna",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol Tablets",
"DosageFormName": "KIT",
"StartMarketingDate": "20220609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079221",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "Loryna (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Loryna (drospirenone and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen consisting of 24 peach active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 white inert film coated tablets. Each active tablet consists of black iron oxide, croscarmellose sodium, lactose fast flo, polyethylene glycol, magnesium stearate, polysorbate 80, polyvinyl alcohol, povidone K-30, pregelatinized starch, talc, titanium dioxide, red iron oxide, yellow iron oxide. The inert tablet consists of andydrous lactose, magnesium stearate, povidone K-30, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc and titanium dioxide. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16] cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows."
},
{
"NDCCode": "70700-115-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-115-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0115-85",
"ProductNDC": "70700-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Syeda",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090114",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230302",
"SamplePackage": "N",
"IndicationAndUsage": "Syeda (drospirenone and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.",
"Description": "Syeda (drospirenone/ethinyl estradiol) tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below. 21 yellow tablets each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol 7 inert white tablets. The inactive ingredients are corn starch, crospovidone (Polyplasdone XL), crospovidone (Polyplasdone XL-10), lactose fast flo, macrogol/PEG 3350, magnesium stearate vegetable (kemilub em-f-v), polysorbate 80 (tween 80), polyvinyl alcohol-part. hydrolyzed, povidone k-30 (kollidon K-30), pregelatinized starch (sepistab ST200), talc and titanium dioxide. In addition, each active tablet contains yellow iron oxide. Drospirenone(6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17 -pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows."
},
{
"NDCCode": "70700-116-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-116-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0116-85",
"ProductNDC": "70700-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Altavera",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20220901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079102",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230302",
"SamplePackage": "N",
"IndicationAndUsage": "Altavera is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Altavera (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 peach active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. LevonorgestrelC21H28O2 MW: 312.4. Ethinyl EstradiolC20H24O2 MW: 296.4. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each peach active tablet contains the following inactive ingredients: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide. Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide."
},
{
"NDCCode": "70700-118-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-118-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0118-85",
"ProductNDC": "70700-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vienva",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201088",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. 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. 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": "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 in the active tablet are: corn starch, crospovidone, lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch. The inactive ingredients present in the inert tablet are: corn starch, crospovidone, FD&C Red # 40 lake, D&C Yellow #10 lake, lactose anhydrous, magnesium stearate, povidone."
},
{
"NDCCode": "70700-119-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-119-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0119-85",
"ProductNDC": "70700-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estarylla",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090794",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180305",
"SamplePackage": "N",
"IndicationAndUsage": "Estarylla (norgestimate and ethinyl estradiol tablets, USP),are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of the ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 Aluminum Lake, lactose anhydrous, magnesium stearate, and pregelatinized starch., 2 Each green placebo tablet containing only inert ingredients, as follows: crospovidone, D & C Yellow No.10 Aluminum Lake, FD & C Blue No.2 Aluminum Lake, lactose anhydrous, magnesium stearate, and pregelatinized starch."
},
{
"NDCCode": "70700-120-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-120-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0120-85",
"ProductNDC": "70700-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-lo- Estarylla",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091232",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.18 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide. , 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.6 sunset yellow fcf aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 4 Each green placebo tablet contains only inert ingredients, as follows: crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, lecithin (soya), magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide."
},
{
"NDCCode": "70700-121-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-121-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0121-85",
"ProductNDC": "70700-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-estarylla",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20220901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090793",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.180 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, and pregelatinized starch., 2 Each active light blue tablet contains 0.215 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 3 Each active blue tablet contains 0.250 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 4 Each green tablet contains only inert ingredients, as follows: crospovidone, D &C Yellow No.10 Aluminum Lake, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch."
},
{
"NDCCode": "70700-122-85",
"PackageDescription": "3 CARTON in 1 CARTON (70700-122-85) / 1 BLISTER PACK in 1 CARTON (70700-122-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0122-85",
"ProductNDC": "70700-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Volnea",
"NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202689",
"LabelerName": "Xiromed, LLC.",
"Status": "Active",
"LastUpdate": "2023-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180222",
"SamplePackage": "N",
"IndicationAndUsage": "Volnea (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets 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 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, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rate. 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. a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) 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. c) 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. d) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly. h) Without spermicides.",
"Description": "Volnea (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include alpha-tocopherol, colloidal silicon dioxide, aquarius cool vanilla (contains hypromellose 2910, polyethylene glycol and titanium dioxide), corn starch, lactose monohydrate, povidone, and stearic acid, followed by 2 inert green round tablets contain the following inactive ingredients: aquarius cottage green (contains FD&C blue no. 2 aluminum lake, hypromellose 2910, polysorbate 80, titanium dioxide, triacetin, and yellow iron oxide), colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and povidone. Volnea also contains 5 yellow round tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include lactose monohydrate, microcrystalline cellulose, magnesium stearate, and opadry yellow (contains lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, and yellow iron oxide). The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows."
},
{
"NDCCode": "70700-152-85",
"PackageDescription": "3 CARTON in 1 CARTON (70700-152-85) / 1 BLISTER PACK in 1 CARTON (70700-152-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0152-85",
"ProductNDC": "70700-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemmily",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213317",
"LabelerName": "Xiromed, LLC",
"Status": "Active",
"LastUpdate": "2023-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Gemmily is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Gemmily in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. Gemmily provides an oral contraceptive regimen consisting of 24 pink active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below: 1 24 oval, opaque, pale pink soft gelatin capsules each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. , 2 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate."
},
{
"NDCCode": "70700-177-85",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70700-177-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0177-85",
"ProductNDC": "70700-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Joyeaux",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20230817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214640",
"LabelerName": "Xiromed, LLC",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230817",
"SamplePackage": "N",
"IndicationAndUsage": "Joyeaux is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Joyeaux (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous fumarate tablets) provides an oral contraceptive regimen consisting of 21 white active tablets and 7 brown inactive tablets. : 1 21 white active tablets each containing 0.10 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, an estrogenic compound, 2 7 brown inactive tablets each containing 75 mg ferrous fumarate."
},
{
"NDCCode": "70700-303-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-303-85) / 1 BLISTER PACK in 1 POUCH (70700-303-84) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "70700-0303-85",
"ProductNDC": "70700-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abigale Lo",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207261",
"LabelerName": "Xiromed LLC",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".5; .1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Abigale and Abigale Lo are indicated for.",
"Description": "Abigale, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Abigale Lo, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Estradiol (E2), is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) is a white or yellowish-white crystalline powder. Its chemical name is 17β -acetoxy-19-nor-17α -pregn-4-en-20-yn-3-one with the empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows."
},
{
"NDCCode": "70700-304-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-304-85) / 1 BLISTER PACK in 1 POUCH (70700-304-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0304-85",
"ProductNDC": "70700-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valtya 1/35",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204703",
"LabelerName": "Xiromed LLC",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Valtya 1/35 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Valtya 1/35: Each light orange tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg package is a placebo containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor- 17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Therapeutic class: Oral contraceptive."
},
{
"NDCCode": "70700-305-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-305-85) / 1 BLISTER PACK in 1 POUCH (70700-305-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0305-85",
"ProductNDC": "70700-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valtya 1/50",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204704",
"LabelerName": "Xiromed LLC",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Valtya 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table 1 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.(I). Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.(J). Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press.1. (A) 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. (B) 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. (C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. (D) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. (E) Foams, creams, gels, vaginal suppositories, and vaginal film. (F) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. (G) With spermicidal cream or jelly. (H) Without spermicides. (I) The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). (J) 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 six months of age.",
"Description": "Valtya 1/50: Each orange tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the Valtya 1/50 package is an inert tablet containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Therapeutic class: Oral contraceptive."
},
{
"NDCCode": "70700-306-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0306-85",
"ProductNDC": "70700-306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galbriela",
"NonProprietaryName": "Norethindrone And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203371",
"LabelerName": "Xiromed, LLC",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Galbriela (norethindrone and ethinyl estradiol chewable tablet and ferrous fumarate chewable tablet) is indicated for use by women to prevent pregnancy. The efficacy of Galbriela in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.",
"Description": "Galbriela (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets: 1 24 dark yellow, round tablets each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol, 2 4 brown, round tablets each containing 75 mg ferrous fumarate."
},
{
"NDCCode": "70700-308-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-308-85) / 1 BLISTER PACK in 1 POUCH (70700-308-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0308-85",
"ProductNDC": "70700-308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xelria Fe",
"NonProprietaryName": "Norethindrone And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202086",
"LabelerName": "Xiromed LLC",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Xelria Fe is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Xelria Fe is a combinational contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. The packaging includes 21 yellow tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are. The active yellow norethindrone and ethinyl estradiol tablets (chewable) contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D & C Yellow No.10 Aluminium Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, maltodextrin, povidone K-30, sodium starch glycolate, spearmint flavor and sucralose. The brown tablets contain ferrous fumarate, colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, magnesium stereate, microcrystalline cellulose and povidone K-90.The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. USP Dissolution Test is pending."
},
{
"NDCCode": "70700-309-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-309-85) / 1 BLISTER PACK in 1 POUCH (70700-309-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0309-85",
"ProductNDC": "70700-309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feirza 1.5/30 Tm",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol Tablets Usp, 1.5 Mg/30 Mcg And Ferrous Fumarate Tablets, 75 Mg",
"DosageFormName": "KIT",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202741",
"LabelerName": "Xiromed LLC",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Feirza 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. *** N/A - Data not available.",
"Description": "Feirza 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) is a progestogen-estrogen combination. Feirza 1.5/30 provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each blue tablet contains norethindrone acetate (19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)), 1.5 mg; ethinyl estradiol (19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α)-), 30 mcg. Also contains compressible sugar, croscarmellose sodium, dl-α-tocopherol, FD & C Blue No. 1 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, povidone K-25, sodium lauryl sulphate. The structural formulas are as follows. Each brown placebo tablet contains colloidal silicon dioxide, croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-90. The ferrous fumarate tablets do not serve any therapeutic purpose."
},
{
"NDCCode": "70700-310-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-310-85) / 1 BLISTER PACK in 1 POUCH (70700-310-84) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0310-85",
"ProductNDC": "70700-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xarah Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate Tablets",
"DosageFormName": "KIT",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205069",
"LabelerName": "Xiromed LLC",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Xarah Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Xarah Fe is indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Xarah Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ¶Foams, creams, gels, vaginal suppositories, and vaginal film. : 1 #Þ Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.",
"Description": "Xarah Fe is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Xarah Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off white tablet contains 1 mg norethindrone acetate [(17 alpha)- 17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)- 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light purple tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each purple tablet contains 1 mg norethindrone acetate, 35 mcg ethinyl estradiol. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 20 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 30 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 35 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. The structural formulas are as follows. Each brown tablet contains ferrous fumarate, microcrystalline cellulose, lactose monohydrate, polyvinyl pyrrolidone K-90, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Each Xarah Fe blister contains five white to off white tablets, seven light purple tablets, nine purple tablets, and seven brown tablets. These tablets are to be taken in the following order: one white to off white each day for five days, then light purple tablet each day for seven days, followed by one purple tablet each day for nine days, and then one brown tablet each day for seven days."
},
{
"NDCCode": "70700-316-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-316-85) / 1 BLISTER PACK in 1 POUCH (70700-316-84) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "70700-0316-85",
"ProductNDC": "70700-316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orquidea",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201483",
"LabelerName": "Xiromed, LLC",
"SubstanceName": "NORETHINDRONE",
"StrengthNumber": ".35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. 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.",
"Description": "Each peach Orquidea tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include corn starch, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, and povidone. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one. The structural formula follows. Therapeutic class = oral contraceptive."
},
{
"NDCCode": "70700-317-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "70700-0317-85",
"ProductNDC": "70700-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meleya",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200980",
"LabelerName": "Xiromed LLC",
"SubstanceName": "NORETHINDRONE",
"StrengthNumber": ".35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Notes. 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. Estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and Depo-Provera are taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; see the text for the derivation of estimates for the other methods. 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. See the text for the derivation of the estimate for each method. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. 4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 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 The Ovulation and TwoDay methods are based on evaluation of cervical mucus. The Standard Days method avoids intercourse on cycle days 8 through 19. The Symptothermal method is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day. 7 Without spermicides. 8 With spermicidal cream or jelly. 9 ella, Plan B One-Step and Next Choice are the only dedicated products specifically marketed for emergency contraception. The label for Plan B One-Step (one dose is 1 white pill) says to take the pill within 72 hours after unprotected intercourse. Research has shown that all of the brands listed here are effective when used within 120 hours after unprotected sex. The label for Next Choice (one dose is 1 peach pill) says to take 1 pill within 72 hours after unprotected intercourse and another pill 12 hours later. Research has shown that both pills can be taken at the same time with no decrease in efficacy or increase in side effects and that they are effective when used within 120 hours after unprotected sex. The FDA has in addition declared the following 19 brands of oral contraceptives to be safe and effective for emergency contraception: Ogestrel (1 dose is 2 white pills), Nordette (1 dose is 4 light-orange pills), Cryselle, Levora, Low-Ogestrel, Lo/Ovral, or Quasence (1 dose is 4 white pills), Jolessa, Portia, Seasonale or Trivora (1 dose is 4 pink pills), Seasonique (1 dose is 4 light-blue-green pills), Enpresse (one dose is 4 orange pills), Lessina (1 dose is 5 pink pills), Aviane or LoSeasonique (one dose is 5 orange pills), Lutera or Sronyx (one dose is 5 white pills), and Lybrel (one dose is 6 yellow pills). 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. Meleya tablets have not been studied for and are not indicated for use in emergency contraception.",
"Description": "Meleya. Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Yellow No. 10, ethyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and talc. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70700-330-85",
"PackageDescription": "3 POUCH in 1 CARTON (70700-330-85) / 1 BLISTER PACK in 1 POUCH (70700-330-84) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "70700-0330-85",
"ProductNDC": "70700-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abigale",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207261",
"LabelerName": "Xiromed LLC",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": "1; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Abigale and Abigale Lo are indicated for.",
"Description": "Abigale, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Abigale Lo, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Estradiol (E2), is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) is a white or yellowish-white crystalline powder. Its chemical name is 17β -acetoxy-19-nor-17α -pregn-4-en-20-yn-3-one with the empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows."
},
{
"NDCCode": "71921-307-51",
"PackageDescription": "1 KIT in 1 CARTON (71921-307-51) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "71921-0307-51",
"ProductNDC": "71921-307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "KIT",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219106",
"LabelerName": "Florida Pharmaceutical Products, LLC",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine,(2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg (white to off-white, capsule shaped film coated tablets, debossed with “1 C” on one side and plain on other side.) and 1 mg (light blue, capsule shaped film-coated tablets, debossed with “2 C” on one side and plain on other side.) Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: silicified microcrystalline cellulose, maltodextrin, croscarmellose sodium, stearic acid, hypromellose, titanium dioxide, macrogol/polyethylene glycol, triacetin. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "70700-100-07",
"PackageDescription": "1 CAN in 1 CARTON (70700-100-07) > 70 g in 1 CAN",
"NDC11Code": "70700-0100-07",
"ProductNDC": "70700-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Econazole Nitrate Topical Foam, 1%",
"NonProprietaryName": "Econazole Nitrate Topical Foam, 1%",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205175",
"LabelerName": "Xiromed LLC",
"SubstanceName": "ECONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-05-17"
}
]
}
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<IndicationAndUsage>Feirza 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Feirza 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) is a progestogen-estrogen combination. Feirza 1/20 provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off-white tablet contains norethindrone acetate (19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)), 1 mg; ethinyl estradiol (19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α)-), 20 mcg. Also contains compressible sugar, croscarmellose sodium, dl-α-tocopherol, lactose anhydrous, lactose monohydrate, magnesium stearate, povidone K-25, sodium lauryl sulphate. The structural formulas are as follows. Each brown placebo tablet contains colloidal silicon dioxide, croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-90. The ferrous fumarate tablets do not serve any therapeutic purpose.</Description>
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<PackageDescription>25000 g in 1 DRUM (43744-307-85)</PackageDescription>
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<StrengthUnit>g/g</StrengthUnit>
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<LastUpdate>2014-02-04</LastUpdate>
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<PackageDescription>85 g in 1 BOTTLE (59088-307-07) </PackageDescription>
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<ProductNDC>59088-307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidotral 3.88% Roll On</ProprietaryName>
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<StartMarketingDate>20240228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
<Description>Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:.</Description>
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<ProprietaryName>Raw Elements Baby Kids Broad Spectrum Spf30</ProprietaryName>
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<LabelerName>Raw Elements LLC</LabelerName>
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<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
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<PackageDescription>85 g in 1 TUBE (85477-307-85) </PackageDescription>
<NDC11Code>85477-0307-85</NDC11Code>
<ProductNDC>85477-307</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topicaine Ultra</ProprietaryName>
<NonProprietaryName>Topicaine Ultra</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260301</StartMarketingDate>
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<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with: 1 minor burns, 2 sunburn, 3 minor cuts, 4 scrapes, 5 insect bites, 6 minor skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70700-101-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-101-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0101-85</NDC11Code>
<ProductNDC>70700-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol Tablets And Ferrous Fumarate Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209609</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets, 1 mg/20 mcg provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 1 24 white, round tablets each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol., 2 4 brown, round tablets each containing 75 mg ferrous fumarate.</Description>
</NDC>
<NDC>
<NDCCode>70700-104-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-104-85) > 1 KIT in 1 BLISTER PACK (70700-104-84) </PackageDescription>
<NDC11Code>70700-0104-85</NDC11Code>
<ProductNDC>70700-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202507</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70700-113-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-113-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0113-85</NDC11Code>
<ProductNDC>70700-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isibloom</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202789</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isibloom (desogestrel 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. aAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. bAmong 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. cAmong 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. dThe treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). eHowever, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. fThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. gFoams, creams, gels, vaginal suppositories, and vaginal film. hCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. iWith spermicidal cream or jelly. jWithout spermicides. Desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Isibloom (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include alpha-tocopherol, colloidal silicon dioxide, corn starch, FD&C yellow 5 aluminum lake, FD&C yellow 6 aluminum lake, hypromellose 2910, lactose monohydrate, polysorbate, povidone, red iron oxide, stearic acid, titanium dioxide and triacetin. Each green tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue 2 aluminum lake, hypromellose 2910, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow iron oxide. USP Dissolution Test 2 used.</Description>
</NDC>
<NDC>
<NDCCode>70700-114-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-114-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0114-85</NDC11Code>
<ProductNDC>70700-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loryna</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079221</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loryna (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Loryna (drospirenone and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen consisting of 24 peach active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 white inert film coated tablets. Each active tablet consists of black iron oxide, croscarmellose sodium, lactose fast flo, polyethylene glycol, magnesium stearate, polysorbate 80, polyvinyl alcohol, povidone K-30, pregelatinized starch, talc, titanium dioxide, red iron oxide, yellow iron oxide. The inert tablet consists of andydrous lactose, magnesium stearate, povidone K-30, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc and titanium dioxide. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16] cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>70700-115-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-115-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0115-85</NDC11Code>
<ProductNDC>70700-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Syeda</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090114</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Syeda (drospirenone and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.</IndicationAndUsage>
<Description>Syeda (drospirenone/ethinyl estradiol) tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below. 21 yellow tablets each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol 7 inert white tablets. The inactive ingredients are corn starch, crospovidone (Polyplasdone XL), crospovidone (Polyplasdone XL-10), lactose fast flo, macrogol/PEG 3350, magnesium stearate vegetable (kemilub em-f-v), polysorbate 80 (tween 80), polyvinyl alcohol-part. hydrolyzed, povidone k-30 (kollidon K-30), pregelatinized starch (sepistab ST200), talc and titanium dioxide. In addition, each active tablet contains yellow iron oxide. Drospirenone(6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17 -pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>70700-116-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-116-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0116-85</NDC11Code>
<ProductNDC>70700-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Altavera</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079102</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Altavera is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Altavera (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 peach active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are. LevonorgestrelC21H28O2 MW: 312.4. Ethinyl EstradiolC20H24O2 MW: 296.4. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each peach active tablet contains the following inactive ingredients: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide. Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70700-118-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-118-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0118-85</NDC11Code>
<ProductNDC>70700-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vienva</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201088</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. 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. 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>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 in the active tablet are: corn starch, crospovidone, lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch. The inactive ingredients present in the inert tablet are: corn starch, crospovidone, FD&C Red # 40 lake, D&C Yellow #10 lake, lactose anhydrous, magnesium stearate, povidone.</Description>
</NDC>
<NDC>
<NDCCode>70700-119-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-119-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0119-85</NDC11Code>
<ProductNDC>70700-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estarylla</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090794</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estarylla (norgestimate and ethinyl estradiol tablets, USP),are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of the ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 Aluminum Lake, lactose anhydrous, magnesium stearate, and pregelatinized starch., 2 Each green placebo tablet containing only inert ingredients, as follows: crospovidone, D & C Yellow No.10 Aluminum Lake, FD & C Blue No.2 Aluminum Lake, lactose anhydrous, magnesium stearate, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>70700-120-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-120-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0120-85</NDC11Code>
<ProductNDC>70700-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-lo- Estarylla</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091232</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.18 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide. , 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.6 sunset yellow fcf aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 4 Each green placebo tablet contains only inert ingredients, as follows: crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, lecithin (soya), magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70700-121-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-121-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0121-85</NDC11Code>
<ProductNDC>70700-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-estarylla</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090793</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.180 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, and pregelatinized starch., 2 Each active light blue tablet contains 0.215 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 3 Each active blue tablet contains 0.250 mg norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch, 4 Each green tablet contains only inert ingredients, as follows: crospovidone, D &C Yellow No.10 Aluminum Lake, FD & C Blue No.2 lake, lactose anhydrous, magnesium stearate, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>70700-122-85</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (70700-122-85) / 1 BLISTER PACK in 1 CARTON (70700-122-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0122-85</NDC11Code>
<ProductNDC>70700-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Volnea</ProprietaryName>
<NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202689</ApplicationNumber>
<LabelerName>Xiromed, LLC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Volnea (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets 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 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, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rate. 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. a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) 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. c) 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. d) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly. h) Without spermicides.</IndicationAndUsage>
<Description>Volnea (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include alpha-tocopherol, colloidal silicon dioxide, aquarius cool vanilla (contains hypromellose 2910, polyethylene glycol and titanium dioxide), corn starch, lactose monohydrate, povidone, and stearic acid, followed by 2 inert green round tablets contain the following inactive ingredients: aquarius cottage green (contains FD&C blue no. 2 aluminum lake, hypromellose 2910, polysorbate 80, titanium dioxide, triacetin, and yellow iron oxide), colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and povidone. Volnea also contains 5 yellow round tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include lactose monohydrate, microcrystalline cellulose, magnesium stearate, and opadry yellow (contains lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, and yellow iron oxide). The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>70700-152-85</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (70700-152-85) / 1 BLISTER PACK in 1 CARTON (70700-152-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0152-85</NDC11Code>
<ProductNDC>70700-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemmily</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213317</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemmily is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Gemmily in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. Gemmily provides an oral contraceptive regimen consisting of 24 pink active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below: 1 24 oval, opaque, pale pink soft gelatin capsules each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. , 2 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate.</Description>
</NDC>
<NDC>
<NDCCode>70700-177-85</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70700-177-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0177-85</NDC11Code>
<ProductNDC>70700-177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Joyeaux</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214640</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Joyeaux is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Joyeaux (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous fumarate tablets) provides an oral contraceptive regimen consisting of 21 white active tablets and 7 brown inactive tablets. : 1 21 white active tablets each containing 0.10 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, an estrogenic compound, 2 7 brown inactive tablets each containing 75 mg ferrous fumarate.</Description>
</NDC>
<NDC>
<NDCCode>70700-303-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-303-85) / 1 BLISTER PACK in 1 POUCH (70700-303-84) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0303-85</NDC11Code>
<ProductNDC>70700-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abigale Lo</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207261</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.5; .1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abigale and Abigale Lo are indicated for.</IndicationAndUsage>
<Description>Abigale, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Abigale Lo, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Estradiol (E2), is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) is a white or yellowish-white crystalline powder. Its chemical name is 17β -acetoxy-19-nor-17α -pregn-4-en-20-yn-3-one with the empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows.</Description>
</NDC>
<NDC>
<NDCCode>70700-304-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-304-85) / 1 BLISTER PACK in 1 POUCH (70700-304-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0304-85</NDC11Code>
<ProductNDC>70700-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valtya 1/35</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204703</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valtya 1/35 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Valtya 1/35: Each light orange tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg package is a placebo containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor- 17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Therapeutic class: Oral contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>70700-305-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-305-85) / 1 BLISTER PACK in 1 POUCH (70700-305-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0305-85</NDC11Code>
<ProductNDC>70700-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valtya 1/50</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204704</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Valtya 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table 1 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.(I). Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.(J). Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press.1. (A) 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. (B) 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. (C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. (D) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. (E) Foams, creams, gels, vaginal suppositories, and vaginal film. (F) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. (G) With spermicidal cream or jelly. (H) Without spermicides. (I) The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). (J) 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 six months of age.</IndicationAndUsage>
<Description>Valtya 1/50: Each orange tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the Valtya 1/50 package is an inert tablet containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Therapeutic class: Oral contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>70700-306-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0306-85</NDC11Code>
<ProductNDC>70700-306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galbriela</ProprietaryName>
<NonProprietaryName>Norethindrone And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203371</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galbriela (norethindrone and ethinyl estradiol chewable tablet and ferrous fumarate chewable tablet) is indicated for use by women to prevent pregnancy. The efficacy of Galbriela in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>Galbriela (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets: 1 24 dark yellow, round tablets each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol, 2 4 brown, round tablets each containing 75 mg ferrous fumarate.</Description>
</NDC>
<NDC>
<NDCCode>70700-308-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-308-85) / 1 BLISTER PACK in 1 POUCH (70700-308-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0308-85</NDC11Code>
<ProductNDC>70700-308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xelria Fe</ProprietaryName>
<NonProprietaryName>Norethindrone And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202086</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Xelria Fe is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Xelria Fe is a combinational contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. The packaging includes 21 yellow tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are. The active yellow norethindrone and ethinyl estradiol tablets (chewable) contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D & C Yellow No.10 Aluminium Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, maltodextrin, povidone K-30, sodium starch glycolate, spearmint flavor and sucralose. The brown tablets contain ferrous fumarate, colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, magnesium stereate, microcrystalline cellulose and povidone K-90.The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>70700-309-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-309-85) / 1 BLISTER PACK in 1 POUCH (70700-309-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0309-85</NDC11Code>
<ProductNDC>70700-309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feirza 1.5/30 Tm</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol Tablets Usp, 1.5 Mg/30 Mcg And Ferrous Fumarate Tablets, 75 Mg</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202741</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Feirza 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. *** N/A - Data not available.</IndicationAndUsage>
<Description>Feirza 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) is a progestogen-estrogen combination. Feirza 1.5/30 provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each blue tablet contains norethindrone acetate (19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)), 1.5 mg; ethinyl estradiol (19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α)-), 30 mcg. Also contains compressible sugar, croscarmellose sodium, dl-α-tocopherol, FD & C Blue No. 1 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, povidone K-25, sodium lauryl sulphate. The structural formulas are as follows. Each brown placebo tablet contains colloidal silicon dioxide, croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-90. The ferrous fumarate tablets do not serve any therapeutic purpose.</Description>
</NDC>
<NDC>
<NDCCode>70700-310-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-310-85) / 1 BLISTER PACK in 1 POUCH (70700-310-84) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0310-85</NDC11Code>
<ProductNDC>70700-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xarah Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205069</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Xarah Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Xarah Fe is indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Xarah Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ¶Foams, creams, gels, vaginal suppositories, and vaginal film. : 1 #Þ Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.</IndicationAndUsage>
<Description>Xarah Fe is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Xarah Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off white tablet contains 1 mg norethindrone acetate [(17 alpha)- 17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)- 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light purple tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each purple tablet contains 1 mg norethindrone acetate, 35 mcg ethinyl estradiol. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 20 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 30 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 35 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. The structural formulas are as follows. Each brown tablet contains ferrous fumarate, microcrystalline cellulose, lactose monohydrate, polyvinyl pyrrolidone K-90, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Each Xarah Fe blister contains five white to off white tablets, seven light purple tablets, nine purple tablets, and seven brown tablets. These tablets are to be taken in the following order: one white to off white each day for five days, then light purple tablet each day for seven days, followed by one purple tablet each day for nine days, and then one brown tablet each day for seven days.</Description>
</NDC>
<NDC>
<NDCCode>70700-316-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-316-85) / 1 BLISTER PACK in 1 POUCH (70700-316-84) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0316-85</NDC11Code>
<ProductNDC>70700-316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orquidea</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201483</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>NORETHINDRONE</SubstanceName>
<StrengthNumber>.35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. 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.</IndicationAndUsage>
<Description>Each peach Orquidea tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include corn starch, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, and povidone. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one. The structural formula follows. Therapeutic class = oral contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>70700-317-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0317-85</NDC11Code>
<ProductNDC>70700-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meleya</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200980</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>NORETHINDRONE</SubstanceName>
<StrengthNumber>.35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Notes. 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. Estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and Depo-Provera are taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; see the text for the derivation of estimates for the other methods. 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. See the text for the derivation of the estimate for each method. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. 4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 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 The Ovulation and TwoDay methods are based on evaluation of cervical mucus. The Standard Days method avoids intercourse on cycle days 8 through 19. The Symptothermal method is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day. 7 Without spermicides. 8 With spermicidal cream or jelly. 9 ella, Plan B One-Step and Next Choice are the only dedicated products specifically marketed for emergency contraception. The label for Plan B One-Step (one dose is 1 white pill) says to take the pill within 72 hours after unprotected intercourse. Research has shown that all of the brands listed here are effective when used within 120 hours after unprotected sex. The label for Next Choice (one dose is 1 peach pill) says to take 1 pill within 72 hours after unprotected intercourse and another pill 12 hours later. Research has shown that both pills can be taken at the same time with no decrease in efficacy or increase in side effects and that they are effective when used within 120 hours after unprotected sex. The FDA has in addition declared the following 19 brands of oral contraceptives to be safe and effective for emergency contraception: Ogestrel (1 dose is 2 white pills), Nordette (1 dose is 4 light-orange pills), Cryselle, Levora, Low-Ogestrel, Lo/Ovral, or Quasence (1 dose is 4 white pills), Jolessa, Portia, Seasonale or Trivora (1 dose is 4 pink pills), Seasonique (1 dose is 4 light-blue-green pills), Enpresse (one dose is 4 orange pills), Lessina (1 dose is 5 pink pills), Aviane or LoSeasonique (one dose is 5 orange pills), Lutera or Sronyx (one dose is 5 white pills), and Lybrel (one dose is 6 yellow pills). 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. Meleya tablets have not been studied for and are not indicated for use in emergency contraception.</IndicationAndUsage>
<Description>Meleya. Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Yellow No. 10, ethyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and talc. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70700-330-85</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (70700-330-85) / 1 BLISTER PACK in 1 POUCH (70700-330-84) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0330-85</NDC11Code>
<ProductNDC>70700-330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abigale</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207261</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abigale and Abigale Lo are indicated for.</IndicationAndUsage>
<Description>Abigale, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Abigale Lo, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: maize starch, lactose monohydrate, FD&C Yellow No. 6, copovidone, talc and magnesium stearate. Estradiol (E2), is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) is a white or yellowish-white crystalline powder. Its chemical name is 17β -acetoxy-19-nor-17α -pregn-4-en-20-yn-3-one with the empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows.</Description>
</NDC>
<NDC>
<NDCCode>71921-307-51</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (71921-307-51) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>71921-0307-51</NDC11Code>
<ProductNDC>71921-307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219106</ApplicationNumber>
<LabelerName>Florida Pharmaceutical Products, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine,(2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg (white to off-white, capsule shaped film coated tablets, debossed with “1 C” on one side and plain on other side.) and 1 mg (light blue, capsule shaped film-coated tablets, debossed with “2 C” on one side and plain on other side.) Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: silicified microcrystalline cellulose, maltodextrin, croscarmellose sodium, stearic acid, hypromellose, titanium dioxide, macrogol/polyethylene glycol, triacetin. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>70700-100-07</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (70700-100-07) > 70 g in 1 CAN</PackageDescription>
<NDC11Code>70700-0100-07</NDC11Code>
<ProductNDC>70700-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Econazole Nitrate Topical Foam, 1%</ProprietaryName>
<NonProprietaryName>Econazole Nitrate Topical Foam, 1%</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205175</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>ECONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-17</LastUpdate>
</NDC>
</NDCList>