{
"NDC": [
{
"NDCCode": "65662-403-24",
"PackageDescription": "24 PACKET in 1 CARTON (65662-403-24) > 1 GRANULE, EFFERVESCENT in 1 PACKET",
"NDC11Code": "65662-0403-24",
"ProductNDC": "65662-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Xtra Strength",
"NonProprietaryName": "Anhydrous Citric Acid, Sodium Bicarbonate, And Aspirin",
"DosageFormName": "GRANULE, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20100302",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Bayer Bitterfeld GmbH",
"SubstanceName": "ANHYDROUS CITRIC ACID; SODIUM BICARBONATE; ASPIRIN",
"StrengthNumber": "1000; 1985; 500",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "65662-403-12",
"PackageDescription": "12 PACKET in 1 CARTON (65662-403-12) > 1 GRANULE, EFFERVESCENT in 1 PACKET",
"NDC11Code": "65662-0403-12",
"ProductNDC": "65662-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Xtra Strength",
"NonProprietaryName": "Anhydrous Citric Acid, Sodium Bicarbonate, And Aspirin",
"DosageFormName": "GRANULE, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20100302",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Bayer Bitterfeld GmbH",
"SubstanceName": "ANHYDROUS CITRIC ACID; SODIUM BICARBONATE; ASPIRIN",
"StrengthNumber": "1000; 1985; 500",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "53943-403-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (53943-403-24) > 100 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "53943-0403-24",
"ProductNDC": "53943-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"ProprietaryNameSuffix": "Immediate Release",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079129",
"LabelerName": "Discount Drug Mart",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual cramps. temporarily reduces fever ."
},
{
"NDCCode": "57910-403-22",
"PackageDescription": "1 BOTTLE in 1 CARTON (57910-403-22) > 24 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "57910-0403-22",
"ProductNDC": "57910-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079129",
"LabelerName": "Shasun Pharmaceuticals Limited",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57910-403-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (57910-403-24) > 100 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "57910-0403-24",
"ProductNDC": "57910-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079129",
"LabelerName": "Shasun Pharmaceuticals Limited",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "67777-403-02",
"PackageDescription": "24 BOTTLE, SPRAY in 1 CASE (67777-403-02) / 236.5 mL in 1 BOTTLE, SPRAY (67777-403-01) ",
"NDC11Code": "67777-0403-02",
"ProductNDC": "67777-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Durma Dynawound Cleanser",
"NonProprietaryName": "Wound Cleanser",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170213",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "31722-403-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (31722-403-60) ",
"NDC11Code": "31722-0403-60",
"ProductNDC": "31722-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lubiprostone",
"NonProprietaryName": "Lubiprostone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218640",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LUBIPROSTONE",
"StrengthNumber": ".008",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"Description": "Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose."
},
{
"NDCCode": "51346-403-02",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (51346-403-02) > 30 mL in 1 BOTTLE, PUMP (51346-403-01)",
"NDC11Code": "51346-0403-02",
"ProductNDC": "51346-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provence Air Skin Fit Foundation Pink Beige C01",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "3.24; .9; .57",
"StrengthUnit": "g/30mL; g/30mL; g/30mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"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": "51862-896-02",
"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": "51862-896-03",
"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": "53145-403-03",
"PackageDescription": "90 g in 1 CANISTER (53145-403-03) ",
"NDC11Code": "53145-0403-03",
"ProductNDC": "53145-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Balsamo De Vaca Mascura",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110510",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Menper Distributors Inc.",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "10.5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150510",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains."
},
{
"NDCCode": "55316-403-68",
"PackageDescription": "1656 mL in 1 BOTTLE, PLASTIC (55316-403-68) ",
"NDC11Code": "55316-0403-68",
"ProductNDC": "55316-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "DZA Brands, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150206",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "55316-403-96",
"PackageDescription": "221 mL in 1 BOTTLE, PUMP (55316-403-96) ",
"NDC11Code": "55316-0403-96",
"ProductNDC": "55316-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "DZA Brands, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150206",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "57883-403-02",
"PackageDescription": "57 g in 1 BOTTLE, PLASTIC (57883-403-02) ",
"NDC11Code": "57883-0403-02",
"ProductNDC": "57883-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plexion",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050901",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Brava Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "98; 48",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050901",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "57883-403-04",
"PackageDescription": "10 TUBE in 1 CARTON (57883-403-04) / 4 g in 1 TUBE",
"NDC11Code": "57883-0403-04",
"ProductNDC": "57883-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plexion",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050901",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Brava Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "98; 48",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050901",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "Y",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "59651-403-37",
"PackageDescription": "50 kg in 1 CANISTER (59651-403-37) ",
"NDC11Code": "59651-0403-37",
"ProductNDC": "59651-403",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Erythromycin Lactobionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240110",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ERYTHROMYCIN LACTOBIONATE",
"StrengthNumber": "50",
"StrengthUnit": "kg/50kg",
"Status": "Unfinished",
"LastUpdate": "2024-01-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "10-JAN-24"
},
{
"NDCCode": "60592-403-10",
"PackageDescription": "1000 g in 1 BOTTLE (60592-403-10) ",
"NDC11Code": "60592-0403-10",
"ProductNDC": "60592-403",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241014",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "KALCHEM INTERNATIONAL INC",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-10-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "14-OCT-24"
},
{
"NDCCode": "61442-403-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61442-403-30) ",
"NDC11Code": "61442-0403-30",
"ProductNDC": "61442-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211318",
"LabelerName": "Carlsbad Technology, Inc.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210423",
"SamplePackage": "N"
},
{
"NDCCode": "63323-403-02",
"PackageDescription": "25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01) ",
"NDC11Code": "63323-0403-02",
"ProductNDC": "63323-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosphenytoin",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078052",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
"Description": "Fosphenytoin Sodium Injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed as a 2 mL fill in 5 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin Sodium Injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin Sodium Injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is:. The molecular weight of fosphenytoin is 406.24."
},
{
"NDCCode": "63323-403-10",
"PackageDescription": "10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04) ",
"NDC11Code": "63323-0403-10",
"ProductNDC": "63323-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosphenytoin",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078052",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
"Description": "Fosphenytoin Sodium Injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed as a 2 mL fill in 5 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin Sodium Injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin Sodium Injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is:. The molecular weight of fosphenytoin is 406.24."
},
{
"NDCCode": "63931-4486-1",
"PackageDescription": "150000 mL in 1 DRUM (63931-4486-1) ",
"NDC11Code": "63931-4486-01",
"ProductNDC": "63931-4486",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wl-aab-z-w-403",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220323",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Nanophase Technologies Corporation",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "132",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220323",
"SamplePackage": "N"
},
{
"NDCCode": "64743-403-01",
"PackageDescription": "125 L in 1 CANISTER (64743-403-01) ",
"NDC11Code": "64743-0403-01",
"ProductNDC": "64743-403",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Echinacea 3x",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240424",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Herbamed AG",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/L",
"Status": "Unfinished",
"LastUpdate": "2024-04-25",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "24-APR-24"
},
{
"NDCCode": "69315-136-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (69315-136-01) ",
"NDC11Code": "69315-0136-01",
"ProductNDC": "69315-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090168",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160515",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc."
},
{
"NDCCode": "69315-136-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69315-136-10) ",
"NDC11Code": "69315-0136-10",
"ProductNDC": "69315-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090168",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160515",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc."
},
{
"NDCCode": "69315-137-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (69315-137-01) ",
"NDC11Code": "69315-0137-01",
"ProductNDC": "69315-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090168",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160515",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc."
},
{
"NDCCode": "69315-137-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69315-137-10) ",
"NDC11Code": "69315-0137-10",
"ProductNDC": "69315-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090168",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160515",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc."
},
{
"NDCCode": "69315-138-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (69315-138-01) ",
"NDC11Code": "69315-0138-01",
"ProductNDC": "69315-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090168",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160515",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc."
},
{
"NDCCode": "69315-138-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69315-138-10) ",
"NDC11Code": "69315-0138-10",
"ProductNDC": "69315-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090168",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160515",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc."
}
]
}
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<NDCList>
<NDC>
<NDCCode>65662-403-24</NDCCode>
<PackageDescription>24 PACKET in 1 CARTON (65662-403-24) > 1 GRANULE, EFFERVESCENT in 1 PACKET</PackageDescription>
<NDC11Code>65662-0403-24</NDC11Code>
<ProductNDC>65662-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Xtra Strength</ProprietaryName>
<NonProprietaryName>Anhydrous Citric Acid, Sodium Bicarbonate, And Aspirin</NonProprietaryName>
<DosageFormName>GRANULE, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100302</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<LabelerName>Bayer Bitterfeld GmbH</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; SODIUM BICARBONATE; ASPIRIN</SubstanceName>
<StrengthNumber>1000; 1985; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>65662-403-12</NDCCode>
<PackageDescription>12 PACKET in 1 CARTON (65662-403-12) > 1 GRANULE, EFFERVESCENT in 1 PACKET</PackageDescription>
<NDC11Code>65662-0403-12</NDC11Code>
<ProductNDC>65662-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Xtra Strength</ProprietaryName>
<NonProprietaryName>Anhydrous Citric Acid, Sodium Bicarbonate, And Aspirin</NonProprietaryName>
<DosageFormName>GRANULE, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100302</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Bayer Bitterfeld GmbH</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; SODIUM BICARBONATE; ASPIRIN</SubstanceName>
<StrengthNumber>1000; 1985; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>53943-403-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (53943-403-24) > 100 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>53943-0403-24</NDC11Code>
<ProductNDC>53943-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<ProprietaryNameSuffix>Immediate Release</ProprietaryNameSuffix>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079129</ApplicationNumber>
<LabelerName>Discount Drug Mart</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual cramps. temporarily reduces fever .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57910-403-22</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (57910-403-22) > 24 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>57910-0403-22</NDC11Code>
<ProductNDC>57910-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079129</ApplicationNumber>
<LabelerName>Shasun Pharmaceuticals Limited</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57910-403-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (57910-403-24) > 100 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>57910-0403-24</NDC11Code>
<ProductNDC>57910-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079129</ApplicationNumber>
<LabelerName>Shasun Pharmaceuticals Limited</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67777-403-02</NDCCode>
<PackageDescription>24 BOTTLE, SPRAY in 1 CASE (67777-403-02) / 236.5 mL in 1 BOTTLE, SPRAY (67777-403-01) </PackageDescription>
<NDC11Code>67777-0403-02</NDC11Code>
<ProductNDC>67777-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Durma Dynawound Cleanser</ProprietaryName>
<NonProprietaryName>Wound Cleanser</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-403-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (31722-403-60) </PackageDescription>
<NDC11Code>31722-0403-60</NDC11Code>
<ProductNDC>31722-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lubiprostone</ProprietaryName>
<NonProprietaryName>Lubiprostone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218640</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LUBIPROSTONE</SubstanceName>
<StrengthNumber>.008</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20250527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 g/mol. and a chemical structure as follows. Lubiprostone drug substance occurs as white to off-white powder, is very soluble in diethyl ether and ethanol, and practically insoluble in hexane and water. Lubiprostone capsules is available as an imprinted, oval, soft gelatin capsule in two strengths. Light orange oval capsules contain 8 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, titanium dioxide, medium chain triglycerides, purified water and lecithin. Clear orange oval capsules contain 24 mcg of lubiprostone and the following inactive ingredients: bloom gelatin, sorbitol sorbitan solution, FD&C yellow no. 6 powder, medium chain triglycerides, purified water and lecithin. The capsules are imprinted with black imprinting ink containing black iron oxide, propylene glycol, and hypromellose.</Description>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provence Air Skin Fit Foundation Pink Beige C01</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
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<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
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<StrengthUnit>g/30mL; g/30mL; g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
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<PackageDescription>1 BLISTER PACK in 1 PACKET (51862-896-01) / 1 KIT in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>51862-896</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tilia Fe</ProprietaryName>
<NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202962</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
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<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.</IndicationAndUsage>
<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.</Description>
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<PackageDescription>1 BLISTER PACK in 1 CARTON (51862-896-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0896-02</NDC11Code>
<ProductNDC>51862-896</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tilia Fe</ProprietaryName>
<NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202962</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
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<NDCCode>51862-896-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (51862-896-03) > 1 KIT in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>51862-896</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tilia Fe</ProprietaryName>
<NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202962</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
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<ProductNDC>51862-896</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20201015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202962</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53145-403-03</NDCCode>
<PackageDescription>90 g in 1 CANISTER (53145-403-03) </PackageDescription>
<NDC11Code>53145-0403-03</NDC11Code>
<ProductNDC>53145-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Balsamo De Vaca Mascura</ProprietaryName>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110510</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Menper Distributors Inc.</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55316-403-68</NDCCode>
<PackageDescription>1656 mL in 1 BOTTLE, PLASTIC (55316-403-68) </PackageDescription>
<NDC11Code>55316-0403-68</NDC11Code>
<ProductNDC>55316-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>DZA Brands, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
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<PackageDescription>221 mL in 1 BOTTLE, PUMP (55316-403-96) </PackageDescription>
<NDC11Code>55316-0403-96</NDC11Code>
<ProductNDC>55316-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>DZA Brands, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57883-403-02</NDCCode>
<PackageDescription>57 g in 1 BOTTLE, PLASTIC (57883-403-02) </PackageDescription>
<NDC11Code>57883-0403-02</NDC11Code>
<ProductNDC>57883-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plexion</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Brava Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>98; 48</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050901</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>57883-403-04</NDCCode>
<PackageDescription>10 TUBE in 1 CARTON (57883-403-04) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>57883-0403-04</NDC11Code>
<ProductNDC>57883-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plexion</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Brava Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>98; 48</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050901</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>59651-403-37</NDCCode>
<PackageDescription>50 kg in 1 CANISTER (59651-403-37) </PackageDescription>
<NDC11Code>59651-0403-37</NDC11Code>
<ProductNDC>59651-403</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Erythromycin Lactobionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240110</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ERYTHROMYCIN LACTOBIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>kg/50kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60592-403-10</NDCCode>
<PackageDescription>1000 g in 1 BOTTLE (60592-403-10) </PackageDescription>
<NDC11Code>60592-0403-10</NDC11Code>
<ProductNDC>60592-403</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241014</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>KALCHEM INTERNATIONAL INC</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-OCT-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61442-403-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61442-403-30) </PackageDescription>
<NDC11Code>61442-0403-30</NDC11Code>
<ProductNDC>61442-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211318</ApplicationNumber>
<LabelerName>Carlsbad Technology, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-403-02</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01) </PackageDescription>
<NDC11Code>63323-0403-02</NDC11Code>
<ProductNDC>63323-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosphenytoin</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078052</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Fosphenytoin Sodium Injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed as a 2 mL fill in 5 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin Sodium Injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin Sodium Injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is:. The molecular weight of fosphenytoin is 406.24.</Description>
</NDC>
<NDC>
<NDCCode>63323-403-10</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04) </PackageDescription>
<NDC11Code>63323-0403-10</NDC11Code>
<ProductNDC>63323-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosphenytoin</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078052</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Fosphenytoin Sodium Injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed as a 2 mL fill in 5 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin Sodium Injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin Sodium Injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is:. The molecular weight of fosphenytoin is 406.24.</Description>
</NDC>
<NDC>
<NDCCode>63931-4486-1</NDCCode>
<PackageDescription>150000 mL in 1 DRUM (63931-4486-1) </PackageDescription>
<NDC11Code>63931-4486-01</NDC11Code>
<ProductNDC>63931-4486</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wl-aab-z-w-403</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220323</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Nanophase Technologies Corporation</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>132</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
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