RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "51862-896-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-896-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0896-02",
      "ProductNDC": "51862-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tilia Fe",
      "NonProprietaryName": "Ndac And Ee Tablets And Ferrous Fumarate Tablets",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201015",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202962",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. 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. 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. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the. percentage who experience an accidental pregnancy during the first year if they do not stop use. for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it. perfectly (both consistently and correctly), the percentage who experience an accidental. pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method. for 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 one year. This. estimate was lowered slightly (to 85%) to represent the percent who would become pregnant. within one year among women now relying on reversible methods of contraception if they. abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal. body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second. dose 12 hours after the first dose. The Food and Drug Administration has declared the following. brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1. dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 lightorange. pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow. pills). 10 However, to maintain effective protection against pregnancy, another method of contraception. must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is. reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator's global evaluation. Patients with severe androgen excess were not studied. Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline* Intent To Treat Population. *Numbers rounded to nearest integer. † Limits for 95% Confidence Interval; not adjusted for baseline differences. Norethindrone acetate and ethinyl estradiol tablet users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
      "Description": "Tilia Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia 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 pale yellow 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 yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each light brown tablet contains 1mg norethindrone acetate and 35mcg ethinyl estradiol. Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each pale yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide ,Talc, Macrogol/Polyethylene Glycol, Lecithin (Soya),D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide , Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), D&C Yellow #10 Aluminum Lake, Iron Oxide Yellow, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each light brown tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light brown tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide,Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), Iron Oxide Yellow, Iron Oxide Red, Iron Oxide Black. The structural formulas are as follows. Each brown tablet contains:  Ferrous Fumarate, Micro-crystalline Cellulose, Hydroxypropyl Cellulose, Crospovidone, Magnesium Stearate, Polyvinyl Alcohol, Iron Oxide Yellow, Talc, Polyethylene Glycol 3350, Iron Oxide Red, Lecithin (Soya), Iron Oxide Black. Each Tilia Fe tablet dispenser contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets, and seven brown tablets. These tablets are to be taken in the following order: one pale yellow tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light brown tablet each day for nine days, and then one brown tablet each day for seven days."
    },
    {
      "NDCCode": "51862-896-01",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (51862-896-01)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0896-01",
      "ProductNDC": "51862-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tilia Fe",
      "NonProprietaryName": "Ndac And Ee Tablets And Ferrous Fumarate Tablets",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201015",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202962",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. 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. 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. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the. percentage who experience an accidental pregnancy during the first year if they do not stop use. for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it. perfectly (both consistently and correctly), the percentage who experience an accidental. pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method. for 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 one year. This. estimate was lowered slightly (to 85%) to represent the percent who would become pregnant. within one year among women now relying on reversible methods of contraception if they. abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal. body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second. dose 12 hours after the first dose. The Food and Drug Administration has declared the following. brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1. dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 lightorange. pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow. pills). 10 However, to maintain effective protection against pregnancy, another method of contraception. must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is. reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator's global evaluation. Patients with severe androgen excess were not studied. Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline* Intent To Treat Population. *Numbers rounded to nearest integer. † Limits for 95% Confidence Interval; not adjusted for baseline differences. Norethindrone acetate and ethinyl estradiol tablet users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
      "Description": "Tilia Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia 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 pale yellow 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 yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each light brown tablet contains 1mg norethindrone acetate and 35mcg ethinyl estradiol. Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each pale yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide ,Talc, Macrogol/Polyethylene Glycol, Lecithin (Soya),D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide , Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), D&C Yellow #10 Aluminum Lake, Iron Oxide Yellow, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each light brown tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light brown tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide,Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), Iron Oxide Yellow, Iron Oxide Red, Iron Oxide Black. The structural formulas are as follows. Each brown tablet contains:  Ferrous Fumarate, Micro-crystalline Cellulose, Hydroxypropyl Cellulose, Crospovidone, Magnesium Stearate, Polyvinyl Alcohol, Iron Oxide Yellow, Talc, Polyethylene Glycol 3350, Iron Oxide Red, Lecithin (Soya), Iron Oxide Black. Each Tilia Fe tablet dispenser contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets, and seven brown tablets. These tablets are to be taken in the following order: one pale yellow tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light brown tablet each day for nine days, and then one brown tablet each day for seven days."
    },
    {
      "NDCCode": "51862-896-03",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (51862-896-03)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0896-03",
      "ProductNDC": "51862-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tilia Fe",
      "NonProprietaryName": "Ndac And Ee Tablets And Ferrous Fumarate Tablets",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201015",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202962",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20201015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. 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. 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. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the. percentage who experience an accidental pregnancy during the first year if they do not stop use. for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it. perfectly (both consistently and correctly), the percentage who experience an accidental. pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method. for 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 one year. This. estimate was lowered slightly (to 85%) to represent the percent who would become pregnant. within one year among women now relying on reversible methods of contraception if they. abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal. body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second. dose 12 hours after the first dose. The Food and Drug Administration has declared the following. brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1. dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 lightorange. pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow. pills). 10 However, to maintain effective protection against pregnancy, another method of contraception. must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is. reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator's global evaluation. Patients with severe androgen excess were not studied. Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline* Intent To Treat Population. *Numbers rounded to nearest integer. † Limits for 95% Confidence Interval; not adjusted for baseline differences. Norethindrone acetate and ethinyl estradiol tablet users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
      "Description": "Tilia Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia 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 pale yellow 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 yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each light brown tablet contains 1mg norethindrone acetate and 35mcg ethinyl estradiol. Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each pale yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide ,Talc, Macrogol/Polyethylene Glycol, Lecithin (Soya),D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide , Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), D&C Yellow #10 Aluminum Lake, Iron Oxide Yellow, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each light brown tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light brown tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide,Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), Iron Oxide Yellow, Iron Oxide Red, Iron Oxide Black. The structural formulas are as follows. Each brown tablet contains:  Ferrous Fumarate, Micro-crystalline Cellulose, Hydroxypropyl Cellulose, Crospovidone, Magnesium Stearate, Polyvinyl Alcohol, Iron Oxide Yellow, Talc, Polyethylene Glycol 3350, Iron Oxide Red, Lecithin (Soya), Iron Oxide Black. Each Tilia Fe tablet dispenser contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets, and seven brown tablets. These tablets are to be taken in the following order: one pale yellow tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light brown tablet each day for nine days, and then one brown tablet each day for seven days."
    },
    {
      "NDCCode": "51862-896-06",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-896-06)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0896-06",
      "ProductNDC": "51862-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tilia Fe",
      "NonProprietaryName": "Ndac And Ee Tablets And Ferrous Fumarate Tablets",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201015",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202962",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. 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. 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. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the. percentage who experience an accidental pregnancy during the first year if they do not stop use. for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it. perfectly (both consistently and correctly), the percentage who experience an accidental. pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method. for 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 one year. This. estimate was lowered slightly (to 85%) to represent the percent who would become pregnant. within one year among women now relying on reversible methods of contraception if they. abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal. body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second. dose 12 hours after the first dose. The Food and Drug Administration has declared the following. brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1. dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 lightorange. pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow. pills). 10 However, to maintain effective protection against pregnancy, another method of contraception. must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is. reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator's global evaluation. Patients with severe androgen excess were not studied. Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline* Intent To Treat Population. *Numbers rounded to nearest integer. † Limits for 95% Confidence Interval; not adjusted for baseline differences. Norethindrone acetate and ethinyl estradiol tablet users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
      "Description": "Tilia Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia 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 pale yellow 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 yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each light brown tablet contains 1mg norethindrone acetate and 35mcg ethinyl estradiol. Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each pale yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide ,Talc, Macrogol/Polyethylene Glycol, Lecithin (Soya),D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide , Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), D&C Yellow #10 Aluminum Lake, Iron Oxide Yellow, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each light brown tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light brown tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide,Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), Iron Oxide Yellow, Iron Oxide Red, Iron Oxide Black. The structural formulas are as follows. Each brown tablet contains:  Ferrous Fumarate, Micro-crystalline Cellulose, Hydroxypropyl Cellulose, Crospovidone, Magnesium Stearate, Polyvinyl Alcohol, Iron Oxide Yellow, Talc, Polyethylene Glycol 3350, Iron Oxide Red, Lecithin (Soya), Iron Oxide Black. Each Tilia Fe tablet dispenser contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets, and seven brown tablets. These tablets are to be taken in the following order: one pale yellow tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light brown tablet each day for nine days, and then one brown tablet each day for seven days."
    },
    {
      "NDCCode": "16714-896-02",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-896-02) ",
      "NDC11Code": "16714-0896-02",
      "ProductNDC": "16714-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glipizide",
      "NonProprietaryName": "Glipizide",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203499",
      "LabelerName": "Northstar Rx LLC.",
      "SubstanceName": "GLIPIZIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.",
      "Description": "Glipizide extended-release tablets, USP are an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a white to off-white powder, with a pKa of 5.9. It is freely soluble in dimethylformamide, soluble in 0.1N sodium hydroxide and slightly soluble in methylene chloride. Glipizide extended-release tablets, USP are formulated as a once-a-day extended-release tablet for oral use and are designed to deliver 2.5 mg, 5 mg, or 10 mg of glipizide. Each glipizide extended-release tablet, USP contains the following inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer and polyethylene glycol. Additionally each 2.5 mg tablet contains: FD&C yellow #5 aluminum lake and titanium dioxide. Each 5 mg tablet contains: FD&C yellow #6 aluminum lake and titanium dioxide. The tablet is imprinted with opacode black S-1-17823 which contains following ingredients: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. System Components and Performance. Glipizide extended-release tablets are formulated as once-a-day extended-release tablets and are designed to deliver glipizide at a controlled rate over approximately 20 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet containing the drug which is surrounded by a seal coat followed by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters in the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases the drug at a controlled rate via diffusion and/or erosion."
    },
    {
      "NDCCode": "30775-053-02",
      "PackageDescription": "12 TUBE in 1 BOX (30775-053-02)  > 58.896 g in 1 TUBE",
      "NDC11Code": "30775-0053-02",
      "ProductNDC": "30775-053",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Helix",
      "NonProprietaryName": "Cbd Therapy Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Parker Laboratories, Inc.",
      "SubstanceName": "MENTHOL, UNSPECIFIED FORM",
      "StrengthNumber": "7.4",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20211004",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52125-896-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-896-02)",
      "NDC11Code": "52125-0896-02",
      "ProductNDC": "52125-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trihexyphenidyl Hydrochloride",
      "NonProprietaryName": "Trihexyphenidyl Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140404",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084363",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "TRIHEXYPHENIDYL HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-22"
    },
    {
      "NDCCode": "54458-896-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-896-02)",
      "NDC11Code": "54458-0896-02",
      "ProductNDC": "54458-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Citalopram",
      "NonProprietaryName": "Citalopram",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077534",
      "LabelerName": "International Labs, Inc.",
      "SubstanceName": "CITALOPRAM HYDROBROMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-04-04"
    },
    {
      "NDCCode": "61786-896-02",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (61786-896-02)",
      "NDC11Code": "61786-0896-02",
      "ProductNDC": "61786-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160919",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090548",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-13"
    },
    {
      "NDCCode": "63545-896-02",
      "PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-896-02) ",
      "NDC11Code": "63545-0896-02",
      "ProductNDC": "63545-896",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aluminium Phosphoricum",
      "NonProprietaryName": "Aluminium Phosphoricum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200429",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ALUMINUM PHOSPHATE",
      "StrengthNumber": "10",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200429",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69097-896-02",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69097-896-02) ",
      "NDC11Code": "69097-0896-02",
      "ProductNDC": "69097-896",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170330",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207378",
      "LabelerName": "Cipla USA Inc.,",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-01-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules, USP are indicated as adjunctive therapy to diet for the reduction of LDLC, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (See WARNINGS and PRECAUTIONS).",
      "Description": "Fenofibrate capsules, USP (micronized) are a lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2- methylpropanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Each 67 mg fenofibrate capsule contains the following inactive ingredients: lactose monohydrate, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, FD&C Blue No.1, FD&C Red No.3, D&C Yellow No.10, titanium dioxide and gelatin. Each 134 mg fenofibrate capsule contains the following inactive ingredients: lactose monohydrate, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, FD&C Blue No.1, D&C Red No.28, titanium dioxide and gelatin. Each 200 mg fenofibrate capsule contains the following inactive ingredients: lactose monohydrate, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No.6, titanium dioxide and gelatin. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.  USP dissolution test is pending."
    },
    {
      "NDCCode": "69423-896-02",
      "PackageDescription": "2 TUBE in 1 CARTON (69423-896-02)  / 119 g in 1 TUBE",
      "NDC11Code": "69423-0896-02",
      "ProductNDC": "69423-896",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kids Crest",
      "ProprietaryNameSuffix": "Advanced Fluoride Anticavity Color Changing",
      "NonProprietaryName": "Stannous Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20230101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": "1.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230101",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps protect against cavities."
    },
    {
      "NDCCode": "84682-896-02",
      "PackageDescription": "15 g in 1 BOX (84682-896-02) ",
      "NDC11Code": "84682-0896-02",
      "ProductNDC": "84682-896",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Carrot Cream",
      "NonProprietaryName": "Trstay Carrot Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "98132-896-02",
      "PackageDescription": "2 g in 1 JAR (98132-896-02) ",
      "NDC11Code": "98132-0896-02",
      "ProductNDC": "98132-896",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bareminerals Original Foundation Broad Spectrum Spf 15",
      "ProprietaryNameSuffix": "Golden Ivory",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Orveon Global US LLC",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170201",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "51862-042-02",
      "PackageDescription": "250 CAPSULE in 1 BOTTLE (51862-042-02) ",
      "NDC11Code": "51862-0042-02",
      "ProductNDC": "51862-042",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline",
      "NonProprietaryName": "Doxycycline",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180309",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209396",
      "LabelerName": "Mayne Pharma Inc.",
      "SubstanceName": "DOXYCYCLINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180309",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51862-135-30",
      "PackageDescription": "30 POUCH in 1 CARTON (51862-135-30)  > 1.83 g in 1 POUCH (51862-135-02)",
      "NDC11Code": "51862-0135-30",
      "ProductNDC": "51862-135",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150316",
      "EndMarketingDate": "20200430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mayne Pharma Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "meq/1.5g",
      "Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-01",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "51862-514-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-514-02)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0514-02",
      "ProductNDC": "51862-514",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201004",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091234",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2022-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201004",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.",
      "Description": "Desogestrel and ethinyl estradiol tablets, USP provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "51862-604-02",
      "PackageDescription": "2 CANISTER in 1 CARTON (51862-604-02)  > 50 g in 1 CANISTER",
      "NDC11Code": "51862-0604-02",
      "ProductNDC": "51862-604",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lexette",
      "NonProprietaryName": "Halobetasol Propionate",
      "DosageFormName": "AEROSOL, FOAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190423",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210566",
      "LabelerName": "Mayne Pharma",
      "SubstanceName": "HALOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190423",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51862-606-02",
      "PackageDescription": "2 CANISTER in 1 CARTON (51862-606-02)  > 50 g in 1 CANISTER",
      "NDC11Code": "51862-0606-02",
      "ProductNDC": "51862-606",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Halobetasol Propionate",
      "NonProprietaryName": "Halobetasol Propionate",
      "DosageFormName": "AEROSOL, FOAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190204",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210566",
      "LabelerName": "Mayne Pharma",
      "SubstanceName": "HALOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190204",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51862-645-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-645-02)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0645-02",
      "ProductNDC": "51862-645",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nymyo",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201011",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090523",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2022-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201011",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
      "Description": "Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
    },
    {
      "NDCCode": "51862-646-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-646-02)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0646-02",
      "ProductNDC": "51862-646",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tri-nymyo",
      "NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201024",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090524",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2022-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201024",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tri-Nymyo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1). Tri-Nymyo is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Nymyo should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
      "Description": "Tri-Nymyo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17 )-(+)-) and ethinyl estradiol is designated as (19-nor-17 -pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active green tablet contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No.2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black,iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol,lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake,titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 4 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
    },
    {
      "NDCCode": "51862-648-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-648-02)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0648-02",
      "ProductNDC": "51862-648",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Microgestin 24 Fe",
      "NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201012",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202994",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2020-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201012",
      "SamplePackage": "N",
      "IndicationAndUsage": "Microgestin 24 Fe is a progestin/estrogen COC indicated for use by women to prevent pregnancy. (1). The efficacy of Microgestin 24 Fe in women with a body mass index (BMI) of >35 kg/m2 has not been evaluated. (1, 8.8).",
      "Description": "Microgestin 24 Fe is a combination oral contraceptive for oral administration consisting of active tablets containing norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, and placebo tablets containing ferrous fumarate, which serve no therapeutic purpose. : 1 Each active pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF, lecithin (soya), D&C Yellow No.10 Aluminum Lake, FD&C Blue No.2 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch., 2 Each placebo brown tablet contains 75 mg ferrous fumarate, polyvinyl alcohol, iron oxide yellow, talc, macrogol/polyethylene glycol 3350 NF, iron oxide red, lecithin (soya), iron oxide black, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate and crospovidone.. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution."
    },
    {
      "NDCCode": "51862-866-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-866-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0866-02",
      "ProductNDC": "51862-866",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Microgestin Fe 1/20",
      "NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201012",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091454",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201012",
      "SamplePackage": "N",
      "IndicationAndUsage": "Microgestin Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
      "Description": "Microgestin Fe 1/20 is progestogen-estrogen combination. Microgestin Fe 1/20: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each pale yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 20 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF,lecithin (soya), D&C Yellow No.10 Aluminum Lake, FD&C Blue No.2 Aluminum Lake, FD&CYellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol,Talc, macrogol/polyethyleneglycol 3350 NF, lecithin (soya),iron oxide black ,iron oxide yellow, microcrystalline cellulose,hydroxypropyl cellulose, magnesium stearate and crospovidone."
    },
    {
      "NDCCode": "51862-868-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-868-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0868-02",
      "ProductNDC": "51862-868",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Microgestin 1/20",
      "NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201012",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202995",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201012",
      "SamplePackage": "N",
      "IndicationAndUsage": "Microgestin 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
      "Description": "Microgestin 1/20 is a progestogen-estrogen combination. Microgestin 1/20 provides a continuous dosage regimen consisting of 21 pale yellow oral contraceptive tablets. Each pale yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 20mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF, lecithin (soya), D&C Yellow No.10 Aluminum Lake, FD&C Blue No.2 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows."
    },
    {
      "NDCCode": "51862-870-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-870-02)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0870-02",
      "ProductNDC": "51862-870",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Microgestin Fe 1.5/30",
      "NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201012",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091453",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2020-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201012",
      "SamplePackage": "N",
      "IndicationAndUsage": "Microgestin Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
      "Description": "Microgestin Fe 1.5/30 is progestogen-estrogen combination. Microgestin Fe 1.5/30: Each provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets and seven brown 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 yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF,lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol,Talc, macrogol/polyethyleneglycol 3350 NF, lecithin (soya),iron oxide black ,iron oxide yellow, microcrystalline cellulose,hydroxypropyl cellulose, magnesium stearate and crospovidone."
    },
    {
      "NDCCode": "51862-872-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-872-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0872-02",
      "ProductNDC": "51862-872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Microgestin 1.5/30",
      "NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201011",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202996",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-07-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201011",
      "SamplePackage": "N",
      "IndicationAndUsage": "Microgestin 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
      "Description": "Microgestin 1.5/30 is a progestogen-estrogen combination. Microgestin 1.5/30 provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets. Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF, lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows."
    },
    {
      "NDCCode": "51862-890-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-890-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0890-02",
      "ProductNDC": "51862-890",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azurette",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20201003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091247",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201003",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azurette (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides."
    },
    {
      "NDCCode": "51862-892-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-892-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "51862-0892-02",
      "ProductNDC": "51862-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Necon",
      "NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201012",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091204",
      "LabelerName": "Mayne Pharma Inc.",
      "Status": "Active",
      "LastUpdate": "2025-09-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201012",
      "SamplePackage": "N",
      "IndicationAndUsage": "Necon Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 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 methods can result in lower failure rates. Necon has not been studied for and is not indicated for use in emergency contraception."
    },
    {
      "NDCCode": "36800-896-65",
      "PackageDescription": "6 POUCH in 1 CARTON (36800-896-65)  > 5 VIAL, SINGLE-USE in 1 POUCH > .4 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "36800-0896-65",
      "ProductNDC": "36800-896",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Lubricant Eye",
      "NonProprietaryName": "Polyethylene Glycol, Propylene Glycol",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20130904",
      "EndMarketingDate": "20200201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
      "StrengthNumber": ".4; .3",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130904",
      "EndMarketingDatePackage": "20200201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37808-896-69",
      "PackageDescription": "1 TUBE in 1 CARTON (37808-896-69)  > 156 g in 1 TUBE (37808-896-62)",
      "NDC11Code": "37808-0896-69",
      "ProductNDC": "37808-896",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Heb",
      "ProprietaryNameSuffix": "Brilliant White",
      "NonProprietaryName": "Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20121001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "HEB",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": ".76",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-23",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"51862-896-02","ProprietaryName":"Tilia Fe","NonProprietaryName":"Ndac And Ee Tablets And Ferrous Fumarate Tablets"},{"NDCCode":"51862-896-01","ProprietaryName":"Tilia Fe","NonProprietaryName":"Ndac And Ee Tablets And Ferrous Fumarate Tablets"},{"NDCCode":"51862-896-03","ProprietaryName":"Tilia Fe","NonProprietaryName":"Ndac And Ee Tablets And Ferrous Fumarate Tablets"},{"NDCCode":"51862-896-06","ProprietaryName":"Tilia Fe","NonProprietaryName":"Ndac And Ee Tablets And Ferrous Fumarate Tablets"},{"NDCCode":"16714-896-02","ProprietaryName":"Glipizide","NonProprietaryName":"Glipizide"},{"NDCCode":"30775-053-02","ProprietaryName":"Helix","NonProprietaryName":"Cbd Therapy Cream"},{"NDCCode":"52125-896-02","ProprietaryName":"Trihexyphenidyl Hydrochloride","NonProprietaryName":"Trihexyphenidyl Hydrochloride"},{"NDCCode":"54458-896-02","ProprietaryName":"Citalopram","NonProprietaryName":"Citalopram"},{"NDCCode":"61786-896-02","ProprietaryName":"Atorvastatin Calcium","NonProprietaryName":"Atorvastatin Calcium"},{"NDCCode":"63545-896-02","ProprietaryName":"Aluminium Phosphoricum","NonProprietaryName":"Aluminium Phosphoricum"},{"NDCCode":"69097-896-02","ProprietaryName":"Fenofibrate","NonProprietaryName":"Fenofibrate"},{"NDCCode":"69423-896-02","ProprietaryName":"Kids Crest","NonProprietaryName":"Stannous Fluoride"},{"NDCCode":"84682-896-02","ProprietaryName":"Trstay Carrot Cream","NonProprietaryName":"Trstay Carrot Cream"},{"NDCCode":"98132-896-02","ProprietaryName":"Bareminerals Original Foundation Broad Spectrum Spf 15","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"51862-042-02","ProprietaryName":"Doxycycline","NonProprietaryName":"Doxycycline"},{"NDCCode":"51862-135-30","ProprietaryName":"Potassium Chloride","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"51862-514-02","ProprietaryName":"Desogestrel And Ethinyl Estradiol","NonProprietaryName":"Desogestrel And Ethinyl Estradiol"},{"NDCCode":"51862-604-02","ProprietaryName":"Lexette","NonProprietaryName":"Halobetasol Propionate"},{"NDCCode":"51862-606-02","ProprietaryName":"Halobetasol Propionate","NonProprietaryName":"Halobetasol Propionate"},{"NDCCode":"51862-645-02","ProprietaryName":"Nymyo","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"51862-646-02","ProprietaryName":"Tri-nymyo","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"51862-648-02","ProprietaryName":"Microgestin 24 Fe","NonProprietaryName":"Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate"},{"NDCCode":"51862-866-02","ProprietaryName":"Microgestin Fe 1/20","NonProprietaryName":"Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate"},{"NDCCode":"51862-868-02","ProprietaryName":"Microgestin 1/20","NonProprietaryName":"Norethindrone Acetate/ethinyl Estradiol"},{"NDCCode":"51862-870-02","ProprietaryName":"Microgestin Fe 1.5/30","NonProprietaryName":"Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate"},{"NDCCode":"51862-872-02","ProprietaryName":"Microgestin 1.5/30","NonProprietaryName":"Norethindrone Acetate/ethinyl Estradiol"},{"NDCCode":"51862-890-02","ProprietaryName":"Azurette","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"51862-892-02","ProprietaryName":"Necon","NonProprietaryName":"Norethindrone And Ethinyl Estradiol"},{"NDCCode":"36800-896-65","ProprietaryName":"Topcare Lubricant Eye","NonProprietaryName":"Polyethylene Glycol, Propylene Glycol"},{"NDCCode":"37808-896-69","ProprietaryName":"Heb","NonProprietaryName":"Fluoride"}]}
                    

<NDCList><NDC><NDCCode>51862-896-02</NDCCode><ProprietaryName>Tilia Fe</ProprietaryName><NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName></NDC><NDC><NDCCode>51862-896-01</NDCCode><ProprietaryName>Tilia Fe</ProprietaryName><NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName></NDC><NDC><NDCCode>51862-896-03</NDCCode><ProprietaryName>Tilia Fe</ProprietaryName><NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName></NDC><NDC><NDCCode>51862-896-06</NDCCode><ProprietaryName>Tilia Fe</ProprietaryName><NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName></NDC><NDC><NDCCode>16714-896-02</NDCCode><ProprietaryName>Glipizide</ProprietaryName><NonProprietaryName>Glipizide</NonProprietaryName></NDC><NDC><NDCCode>30775-053-02</NDCCode><ProprietaryName>Helix</ProprietaryName><NonProprietaryName>Cbd Therapy Cream</NonProprietaryName></NDC><NDC><NDCCode>52125-896-02</NDCCode><ProprietaryName>Trihexyphenidyl Hydrochloride</ProprietaryName><NonProprietaryName>Trihexyphenidyl Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54458-896-02</NDCCode><ProprietaryName>Citalopram</ProprietaryName><NonProprietaryName>Citalopram</NonProprietaryName></NDC><NDC><NDCCode>61786-896-02</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>63545-896-02</NDCCode><ProprietaryName>Aluminium Phosphoricum</ProprietaryName><NonProprietaryName>Aluminium Phosphoricum</NonProprietaryName></NDC><NDC><NDCCode>69097-896-02</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>69423-896-02</NDCCode><ProprietaryName>Kids Crest</ProprietaryName><NonProprietaryName>Stannous Fluoride</NonProprietaryName></NDC><NDC><NDCCode>84682-896-02</NDCCode><ProprietaryName>Trstay Carrot Cream</ProprietaryName><NonProprietaryName>Trstay Carrot Cream</NonProprietaryName></NDC><NDC><NDCCode>98132-896-02</NDCCode><ProprietaryName>Bareminerals Original Foundation Broad Spectrum Spf 15</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>51862-042-02</NDCCode><ProprietaryName>Doxycycline</ProprietaryName><NonProprietaryName>Doxycycline</NonProprietaryName></NDC><NDC><NDCCode>51862-135-30</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>51862-514-02</NDCCode><ProprietaryName>Desogestrel And Ethinyl Estradiol</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>51862-604-02</NDCCode><ProprietaryName>Lexette</ProprietaryName><NonProprietaryName>Halobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>51862-606-02</NDCCode><ProprietaryName>Halobetasol Propionate</ProprietaryName><NonProprietaryName>Halobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>51862-645-02</NDCCode><ProprietaryName>Nymyo</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>51862-646-02</NDCCode><ProprietaryName>Tri-nymyo</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>51862-648-02</NDCCode><ProprietaryName>Microgestin 24 Fe</ProprietaryName><NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName></NDC><NDC><NDCCode>51862-866-02</NDCCode><ProprietaryName>Microgestin Fe 1/20</ProprietaryName><NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName></NDC><NDC><NDCCode>51862-868-02</NDCCode><ProprietaryName>Microgestin 1/20</ProprietaryName><NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>51862-870-02</NDCCode><ProprietaryName>Microgestin Fe 1.5/30</ProprietaryName><NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName></NDC><NDC><NDCCode>51862-872-02</NDCCode><ProprietaryName>Microgestin 1.5/30</ProprietaryName><NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>51862-890-02</NDCCode><ProprietaryName>Azurette</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>51862-892-02</NDCCode><ProprietaryName>Necon</ProprietaryName><NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>36800-896-65</NDCCode><ProprietaryName>Topcare Lubricant Eye</ProprietaryName><NonProprietaryName>Polyethylene Glycol, Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>37808-896-69</NDCCode><ProprietaryName>Heb</ProprietaryName><NonProprietaryName>Fluoride</NonProprietaryName></NDC></NDCList>