{
"NDC": [
{
"NDCCode": "70700-195-35",
"PackageDescription": "30 PACKET in 1 CARTON (70700-195-35) / 1.25 g in 1 PACKET",
"NDC11Code": "70700-0195-35",
"ProductNDC": "70700-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol Gel 0.1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211783",
"LabelerName": "Xiromed, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1.25g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"Description": "Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol, an estrogen. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive. Estradiol gel 0.1% contains: 58.6% alcohol."
},
{
"NDCCode": "70700-143-35",
"PackageDescription": "30 PACKET in 1 CARTON (70700-143-35) / .25 g in 1 PACKET",
"NDC11Code": "70700-0143-35",
"ProductNDC": "70700-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol Gel 0.1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211783",
"LabelerName": "Xiromed, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".25",
"StrengthUnit": "mg/.25g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"Description": "Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol, an estrogen. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive. Estradiol gel 0.1% contains: 58.6% alcohol."
},
{
"NDCCode": "70700-144-35",
"PackageDescription": "30 PACKET in 1 CARTON (70700-144-35) / .5 g in 1 PACKET",
"NDC11Code": "70700-0144-35",
"ProductNDC": "70700-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol Gel 0.1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211783",
"LabelerName": "Xiromed, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".5",
"StrengthUnit": "mg/.5g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"Description": "Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol, an estrogen. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive. Estradiol gel 0.1% contains: 58.6% alcohol."
},
{
"NDCCode": "70700-145-35",
"PackageDescription": "30 PACKET in 1 CARTON (70700-145-35) / 1 g in 1 PACKET",
"NDC11Code": "70700-0145-35",
"ProductNDC": "70700-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol Gel 0.1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211783",
"LabelerName": "Xiromed, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"Description": "Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol, an estrogen. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive. Estradiol gel 0.1% contains: 58.6% alcohol."
},
{
"NDCCode": "70700-194-35",
"PackageDescription": "30 PACKET in 1 CARTON (70700-194-35) / .75 g in 1 PACKET",
"NDC11Code": "70700-0194-35",
"ProductNDC": "70700-194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol Gel 0.1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211783",
"LabelerName": "Xiromed, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".75",
"StrengthUnit": "mg/.75g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"Description": "Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol, an estrogen. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive. Estradiol gel 0.1% contains: 58.6% alcohol."
},
{
"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": "70700-101-85",
"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": "70700-118-85",
"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": "70700-152-85",
"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": "70700-304-85",
"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": "70700-306-85",
"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": "70700-310-85",
"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": "70700-331-24",
"PackageDescription": "5 TRAY in 1 CARTON (70700-331-24) / 5 AMPULE in 1 TRAY (70700-331-25) / 1 mL in 1 AMPULE",
"NDC11Code": "70700-0331-24",
"ProductNDC": "70700-331",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217386",
"LabelerName": "Xiromed LLC",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione Injectable Emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Phytonadione Injectable Emulsion is indicated in: : 1 anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;, 2 prophylaxis and therapy of hemorrhagic disease of the newborn;, 3 hypoprothrombinemia due to antibacterial therapy;, 4 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;, 5 other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is practically insoluble in water, sparingly soluble in ethanol and miscible with fatty oils. It has a molecular weight of 450.70. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-en-1-ylnaphthalene- 1,4-dione. Its empirical formula is C 31H 46O 2 and its structural formula is:. Phytonadione Injectable Emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione, USP 10 mg, polyoxyl 35 castor oil 70 mg, dextrose monohydrate 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive."
},
{
"NDCCode": "70700-331-25",
"PackageDescription": "5 TRAY in 1 CARTON (70700-331-25) / 5 AMPULE in 1 TRAY (70700-331-24) / 1 mL in 1 AMPULE",
"NDC11Code": "70700-0331-25",
"ProductNDC": "70700-331",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217386",
"LabelerName": "Xiromed LLC",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione Injectable Emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Phytonadione Injectable Emulsion is indicated in: 1 anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;, 2 prophylaxis and therapy of hemorrhagic disease of the newborn;, 3 hypoprothrombinemia due to antibacterial therapy;, 4 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;, 5 other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is practically insoluble in water, sparingly soluble in ethanol and miscible with fatty oils. It has a molecular weight of 450.70.Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-en-1-ylnaphthalene- 1,4-dione. Its empirical formula is C31H46O2 and its structural formula is. Phytonadione Injectable Emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione, USP 10 mg, polyoxyl 35 castor oil 70 mg, dextrose monohydrate 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive."
},
{
"NDCCode": "52817-195-00",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (52817-195-00) ",
"NDC11Code": "52817-0195-00",
"ProductNDC": "52817-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208708",
"LabelerName": "TRUPHARMA LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2021-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "52817-195-10",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (52817-195-10) ",
"NDC11Code": "52817-0195-10",
"ProductNDC": "52817-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208708",
"LabelerName": "TRUPHARMA LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2021-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "52817-195-50",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (52817-195-50) ",
"NDC11Code": "52817-0195-50",
"ProductNDC": "52817-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208708",
"LabelerName": "TRUPHARMA LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2021-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide."
},
{
"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"
},
{
"NDCCode": "70700-101-09",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (70700-101-09) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70700-0101-09",
"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": "20180730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209609",
"LabelerName": "Xiromed, LLC",
"Status": "Deprecated",
"LastUpdate": "2018-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180730",
"SamplePackage": "N"
},
{
"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": "70700-104-86",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (70700-104-86) > 1 KIT in 1 BLISTER PACK (70700-104-84) ",
"NDC11Code": "70700-0104-86",
"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": "70700-105-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (70700-105-01) ",
"NDC11Code": "70700-0105-01",
"ProductNDC": "70700-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
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"Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
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"Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
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"Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
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}
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<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>70700-101-85</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>70700-118-85</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>70700-152-85</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>70700-304-85</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>70700-306-85</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>70700-310-85</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>70700-331-24</NDCCode>
<PackageDescription>5 TRAY in 1 CARTON (70700-331-24) / 5 AMPULE in 1 TRAY (70700-331-25) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>70700-0331-24</NDC11Code>
<ProductNDC>70700-331</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217386</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione Injectable Emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Phytonadione Injectable Emulsion is indicated in: : 1 anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;, 2 prophylaxis and therapy of hemorrhagic disease of the newborn;, 3 hypoprothrombinemia due to antibacterial therapy;, 4 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;, 5 other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is practically insoluble in water, sparingly soluble in ethanol and miscible with fatty oils. It has a molecular weight of 450.70. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-en-1-ylnaphthalene- 1,4-dione. Its empirical formula is C 31H 46O 2 and its structural formula is:. Phytonadione Injectable Emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione, USP 10 mg, polyoxyl 35 castor oil 70 mg, dextrose monohydrate 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.</Description>
</NDC>
<NDC>
<NDCCode>70700-331-25</NDCCode>
<PackageDescription>5 TRAY in 1 CARTON (70700-331-25) / 5 AMPULE in 1 TRAY (70700-331-24) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>70700-0331-25</NDC11Code>
<ProductNDC>70700-331</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217386</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione Injectable Emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Phytonadione Injectable Emulsion is indicated in: 1 anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;, 2 prophylaxis and therapy of hemorrhagic disease of the newborn;, 3 hypoprothrombinemia due to antibacterial therapy;, 4 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;, 5 other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is practically insoluble in water, sparingly soluble in ethanol and miscible with fatty oils. It has a molecular weight of 450.70.Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-en-1-ylnaphthalene- 1,4-dione. Its empirical formula is C31H46O2 and its structural formula is. Phytonadione Injectable Emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione, USP 10 mg, polyoxyl 35 castor oil 70 mg, dextrose monohydrate 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.</Description>
</NDC>
<NDC>
<NDCCode>52817-195-00</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (52817-195-00) </PackageDescription>
<NDC11Code>52817-0195-00</NDC11Code>
<ProductNDC>52817-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208708</ApplicationNumber>
<LabelerName>TRUPHARMA LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2021-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52817-195-10</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (52817-195-10) </PackageDescription>
<NDC11Code>52817-0195-10</NDC11Code>
<ProductNDC>52817-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208708</ApplicationNumber>
<LabelerName>TRUPHARMA LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2021-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52817-195-50</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE (52817-195-50) </PackageDescription>
<NDC11Code>52817-0195-50</NDC11Code>
<ProductNDC>52817-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208708</ApplicationNumber>
<LabelerName>TRUPHARMA LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2021-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.</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>
<NDC>
<NDCCode>70700-101-09</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (70700-101-09) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70700-0101-09</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>20180730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209609</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>70700-104-86</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (70700-104-86) > 1 KIT in 1 BLISTER PACK (70700-104-84) </PackageDescription>
<NDC11Code>70700-0104-86</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>70700-105-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70700-105-01) </PackageDescription>
<NDC11Code>70700-0105-01</NDC11Code>
<ProductNDC>70700-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207574</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70700-105-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (70700-105-05) </PackageDescription>
<NDC11Code>70700-0105-05</NDC11Code>
<ProductNDC>70700-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207574</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70700-106-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (70700-106-15) </PackageDescription>
<NDC11Code>70700-0106-15</NDC11Code>
<ProductNDC>70700-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209701</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>70700-106-16</NDCCode>
<PackageDescription>30 g in 1 TUBE (70700-106-16) </PackageDescription>
<NDC11Code>70700-0106-16</NDC11Code>
<ProductNDC>70700-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209701</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>70700-106-17</NDCCode>
<PackageDescription>60 g in 1 TUBE (70700-106-17) </PackageDescription>
<NDC11Code>70700-0106-17</NDC11Code>
<ProductNDC>70700-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209701</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>70700-106-18</NDCCode>
<PackageDescription>45 g in 1 TUBE (70700-106-18) </PackageDescription>
<NDC11Code>70700-0106-18</NDC11Code>
<ProductNDC>70700-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209701</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>70700-107-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70700-107-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>70700-0107-15</NDC11Code>
<ProductNDC>70700-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201501</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous HSV infections in immunocompromised patients.</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
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