{
"NDC": [
{
"NDCCode": "52584-870-21",
"PackageDescription": "1 VIAL in 1 BAG (52584-870-21) > 2 mL in 1 VIAL",
"NDC11Code": "52584-0870-21",
"ProductNDC": "52584-870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cleocin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20121019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050441",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180726",
"SamplePackage": "N"
},
{
"NDCCode": "17224-870-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (17224-870-21) ",
"NDC11Code": "17224-0870-21",
"ProductNDC": "17224-870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040886",
"LabelerName": "Calvin Scott & Co., Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120807",
"SamplePackage": "N"
},
{
"NDCCode": "52584-078-21",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (52584-078-21) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52584-0078-21",
"ProductNDC": "52584-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20180703",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083312",
"LabelerName": "General Injectables and Vaccines, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180703",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.",
"Description": "Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed."
},
{
"NDCCode": "52584-376-21",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (52584-376-21) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52584-0376-21",
"ProductNDC": "52584-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100701",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080817",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100701",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic-For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness-For active treatment of motion sickness. Antiparkinsonism-For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases at parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.",
"Description": "Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows. C17H21NO HCl MW 291.82. Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol."
},
{
"NDCCode": "52584-493-21",
"PackageDescription": "1 VIAL in 1 BAG (52584-493-21) > 2 mL in 1 VIAL",
"NDC11Code": "52584-0493-21",
"ProductNDC": "52584-493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084307",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "PHENYTOIN 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": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100301",
"SamplePackage": "N"
},
{
"NDCCode": "0378-7287-53",
"PackageDescription": "3 POUCH in 1 CARTON (0378-7287-53) / 1 BLISTER PACK in 1 POUCH (0378-7287-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00378-7287-53",
"ProductNDC": "0378-7287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200245",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140626",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
"Description": "Each active, light yellow tablet (21) contains 0.1 mg of levonorgestrel, d(-)-13-β-ethyl-17-α-ethinyl-17-β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17-α-ethinyl-1,3,5(10)-estratriene-3,17-β-diol. The inactive ingredients present are croscarmellose sodium, ferric oxide of iron (yellow), ferric oxide of iron (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-25, and sodium lauryl sulfate. Each inactive, brown tablet (7) contains the following inactive ingredients: croscarmellose sodium, ferric oxide of iron (brown), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone K-25."
},
{
"NDCCode": "0555-9045-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9045-58",
"ProductNDC": "0555-9045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aviane",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20010402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075796",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2024-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010402",
"SamplePackage": "N",
"IndicationAndUsage": "Aviane (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Aviane (levonorgestrel and ethinyl estradiol tablets) in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with Aviane (levonorgestrel and ethinyl estradiol tablets), 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. 7 light-green, inert tablets each containing: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Levonorgestrel, USP. C21H28O2 M.W. 312.45. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "13537-870-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-870-02) > 4 g in 1 TUBE (13537-870-01)",
"NDC11Code": "13537-0870-02",
"ProductNDC": "13537-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effet Parfait Rouge Amplifier",
"ProprietaryNameSuffix": "Amplifying Spf 15 (rouge Grandiose) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140911",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".072",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-870-01",
"PackageDescription": "30 g in 1 TUBE (14141-870-01) ",
"NDC11Code": "14141-0870-01",
"ProductNDC": "14141-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20 Almendra 230-n",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BEL STAR S A",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "4; 2.4",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "14783-870-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-870-02) > 4 g in 1 TUBE (14783-870-01)",
"NDC11Code": "14783-0870-02",
"ProductNDC": "14783-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effet Parfait Rouge Amplifier",
"ProprietaryNameSuffix": "Amplifying Spf 15 (rouge Grandiose) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140911",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".072",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-359-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0359-01",
"ProductNDC": "16714-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Falmina",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090721",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-359-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0359-02",
"ProductNDC": "16714-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Falmina",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090721",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-359-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-359-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0359-03",
"ProductNDC": "16714-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Falmina",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090721",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-359-04",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (16714-359-04) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0359-04",
"ProductNDC": "16714-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Falmina",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090721",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "21695-870-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (21695-870-20) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "21695-0870-20",
"ProductNDC": "21695-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021282",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "21695-870-40",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (21695-870-40) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "21695-0870-40",
"ProductNDC": "21695-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021282",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "21695-995-28",
"PackageDescription": "1 BLISTER PACK in 1 POUCH (21695-995-28) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "21695-0995-28",
"ProductNDC": "21695-995",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aviane",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "19950824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075796",
"LabelerName": "Rebel Distributors Corp",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Aviane is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with levonorgestrel and ethinyl estradiol 0.10 mg/0.02 mg tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of back-up contraception and/or missing 3 or more consecutive pills.",
"Description": "21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate and titanium dioxide. 7 Light-green, inert tablets each contain: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch."
},
{
"NDCCode": "31722-944-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (31722-944-32) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "31722-0944-32",
"ProductNDC": "31722-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonorgetsrel And Ethinyl Estradiol",
"NonProprietaryName": "Levonorgetsrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20230213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212298",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2023-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230213",
"SamplePackage": "N",
"IndicationAndUsage": "Levonorgestrel and Ethinyl Estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 2: Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The proportion of women who become pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the proportion who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
"Description": "21 white active tablets each containing 0.1 mg of levonorgestrel USP, (17α)-(-)-13-ethyl-17-hydroxy-18,19, dinorpregna-4-en-20-yn-3-one, and 0.02 mg of ethinyl estradiol USP, 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17β-diol. The inactive ingredients present are cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone. 7 orange inert tablets, each containing cellulose microcrystalline, colloidal silicon dioxide, FD&C Red#40, FD&C Yellow#6, iron oxide yellow, lactose monohydrate, magnesium stearate. Levonorgestrel C 21H 28O 2 M.W. 312.5 Ethinyl Estradiol C 20H 24O 2 M.W. 296.41."
},
{
"NDCCode": "35000-870-02",
"PackageDescription": "56.6 g in 1 CONTAINER (35000-870-02)",
"NDC11Code": "35000-0870-02",
"ProductNDC": "35000-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Speed Stick",
"ProprietaryNameSuffix": "Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111207",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "160",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "35000-870-03",
"PackageDescription": "85 g in 1 CONTAINER (35000-870-03)",
"NDC11Code": "35000-0870-03",
"ProductNDC": "35000-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Speed Stick",
"ProprietaryNameSuffix": "Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111207",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "160",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "36800-518-34",
"PackageDescription": "237 mL in 1 BOTTLE (36800-518-34) ",
"NDC11Code": "36800-0518-34",
"ProductNDC": "36800-518",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Pain Reliever Simple Relief",
"NonProprietaryName": "Caffeine, Choline Salicylate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20160906",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "TOPCO ASSOCIATES LLC",
"SubstanceName": "CAFFEINE; CHOLINE SALICYLATE",
"StrengthNumber": "65; 870",
"StrengthUnit": "mg/30mL; mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20160906",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:○ headache○ minor arthritis pain○ muscle aches○ menstrual cramps○ backache. temporarily reduces fever."
},
{
"NDCCode": "36800-888-08",
"PackageDescription": "237 mL in 1 BOTTLE (36800-888-08) ",
"NDC11Code": "36800-0888-08",
"ProductNDC": "36800-888",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Nighttime Cold And Flu Simple Relief",
"NonProprietaryName": "Choline Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160906",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TOPCO ASSOCIATES LLC",
"SubstanceName": "CHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "870; 50; 10",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160906",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms. ▪ nasal congestion. ▪ minor aches and pains. ▪ runny nose. ▪ sneezing. ▪ watery eyes. ▪ sore throat. ▪ headache. ▪ temporarily reduces fever."
},
{
"NDCCode": "37945-876-91",
"PackageDescription": "1 KIT in 1 KIT (37945-876-91) * 236.558 mL in 1 BOTTLE * 1 BOTTLE in 1 BOX (37945-874-11) > 30 mL in 1 BOTTLE * 1 APPLICATOR in 1 BOX (37945-894-05) > 15 mL in 1 APPLICATOR * 1 BOTTLE, PUMP in 1 BOX (37945-870-40) > 118 mL in 1 BOTTLE, PUMP",
"NDC11Code": "37945-0876-91",
"ProductNDC": "37945-876",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kleer-plex Advanced Acne Care System",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "KIT",
"StartMarketingDate": "20141103",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Bio-Medical & Pharmaceutical Manufacturing Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the management of acne. Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal. Penetrates pores to eliminate most acne blemishes. Helps prevent new acne pimples."
},
{
"NDCCode": "50090-1380-0",
"PackageDescription": "1 KIT in 1 KIT (50090-1380-0) * 21 TABLET, FILM COATED in 1 KIT * 7 TABLET, FILM COATED in 1 KIT",
"NDC11Code": "50090-1380-00",
"ProductNDC": "50090-1380",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orsythia",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077099",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "Y",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "ORSYTHIA® (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and levonorgestrel implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of back-up contraception and/or missing 3 or more consecutive pills.",
"Description": "21 pink active tablets each containing 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are FD&C red #40 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and vitamin E. 7 light-green inert tablets, each containing FD&C blue #2, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol and pregelatinized starch."
},
{
"NDCCode": "50090-5580-0",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (50090-5580-0) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50090-5580-00",
"ProductNDC": "50090-5580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vienva Tm",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201088",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210702",
"SamplePackage": "N",
"IndicationAndUsage": "Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.",
"Description": "Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present in the active tablet are: corn starch, crospovidone, lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch. The inactive ingredients present in the inert tablet are: corn starch, crospovidone, FD&C Red # 40 lake, D&C Yellow #10 lake, lactose anhydrous, magnesium stearate, povidone."
},
{
"NDCCode": "50102-220-23",
"PackageDescription": "3 POUCH in 1 CARTON (50102-220-23) / 1 BLISTER PACK in 1 POUCH (50102-220-21) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50102-0220-23",
"ProductNDC": "50102-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aubra Eq",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206886",
"LabelerName": "Afaxys Pharma, LLC",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Aubra EQ is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
"Description": "Each active, white tablet (21) contains 0.1 mg of levonorgestrel USP, d(-)-13β-ethyl-17α- ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol USP, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive, green tablet (7) contains the following inactive ingredients: croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow 10), lactose anhydrous, magnesium stearate, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "51660-572-86",
"PackageDescription": "1 KIT in 1 CARTON (51660-572-86) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51660-0572-86",
"ProductNDC": "51660-572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delyla",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20140526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201108",
"LabelerName": "OHM LABORATORIES INC.",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "DELYLA is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In: Hatcher RA, Trussell J Stew-art F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
"Description": "Each active, white tablet (21) contains 0.1 mg of levonorgestrel, USP, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish White 014.17 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, talc, and titanium dioxide. Each inactive, yellow tablet (7) contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish Yellow 024.15 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, ferric oxide red, ferric oxide yellow, talc, and titanium dioxide."
},
{
"NDCCode": "51862-028-06",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51862-028-06) / 1 KIT in 1 BLISTER PACK (51862-028-01) ",
"NDC11Code": "51862-0028-06",
"ProductNDC": "51862-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lutera",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076625",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160803",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Lutera is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
"Description": "Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d (-)-13β-ethyl-17α-ethinyl-17β- hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl- 1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive, peach tablet (7) contains the following inactive ingredients: FD&C Yellow #6, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "51862-870-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (51862-870-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0870-01",
"ProductNDC": "51862-870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Microgestin Fe 1.5/30",
"NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20201012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091453",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2020-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201012",
"SamplePackage": "N",
"IndicationAndUsage": "Microgestin Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Microgestin Fe 1.5/30 is progestogen-estrogen combination. Microgestin Fe 1.5/30: Each provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets and seven brown ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF,lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol,Talc, macrogol/polyethyleneglycol 3350 NF, lecithin (soya),iron oxide black ,iron oxide yellow, microcrystalline cellulose,hydroxypropyl cellulose, magnesium stearate and crospovidone."
},
{
"NDCCode": "51862-870-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-870-02) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51862-0870-02",
"ProductNDC": "51862-870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Microgestin Fe 1.5/30",
"NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20201012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091453",
"LabelerName": "Mayne Pharma Inc.",
"Status": "Active",
"LastUpdate": "2020-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201012",
"SamplePackage": "N",
"IndicationAndUsage": "Microgestin Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Microgestin Fe 1.5/30 is progestogen-estrogen combination. Microgestin Fe 1.5/30: Each provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets and seven brown ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF,lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol,Talc, macrogol/polyethyleneglycol 3350 NF, lecithin (soya),iron oxide black ,iron oxide yellow, microcrystalline cellulose,hydroxypropyl cellulose, magnesium stearate and crospovidone."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52584-870-21</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (52584-870-21) > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>52584-0870-21</NDC11Code>
<ProductNDC>52584-870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cleocin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20121019</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050441</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17224-870-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (17224-870-21) </PackageDescription>
<NDC11Code>17224-0870-21</NDC11Code>
<ProductNDC>17224-870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040886</ApplicationNumber>
<LabelerName>Calvin Scott & Co., Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52584-078-21</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (52584-078-21) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52584-0078-21</NDC11Code>
<ProductNDC>52584-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20180703</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083312</ApplicationNumber>
<LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180703</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.</IndicationAndUsage>
<Description>Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.</Description>
</NDC>
<NDC>
<NDCCode>52584-376-21</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (52584-376-21) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52584-0376-21</NDC11Code>
<ProductNDC>52584-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080817</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100701</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic-For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness-For active treatment of motion sickness. Antiparkinsonism-For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases at parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.</IndicationAndUsage>
<Description>Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows. C17H21NO HCl MW 291.82. Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>52584-493-21</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (52584-493-21) > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>52584-0493-21</NDC11Code>
<ProductNDC>52584-493</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084307</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>PHENYTOIN 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>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-7287-53</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (0378-7287-53) / 1 BLISTER PACK in 1 POUCH (0378-7287-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00378-7287-53</NDC11Code>
<ProductNDC>0378-7287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200245</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>Each active, light yellow tablet (21) contains 0.1 mg of levonorgestrel, d(-)-13-β-ethyl-17-α-ethinyl-17-β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17-α-ethinyl-1,3,5(10)-estratriene-3,17-β-diol. The inactive ingredients present are croscarmellose sodium, ferric oxide of iron (yellow), ferric oxide of iron (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-25, and sodium lauryl sulfate. Each inactive, brown tablet (7) contains the following inactive ingredients: croscarmellose sodium, ferric oxide of iron (brown), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone K-25.</Description>
</NDC>
<NDC>
<NDCCode>0555-9045-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9045-58</NDC11Code>
<ProductNDC>0555-9045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aviane</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20010402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075796</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aviane (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Aviane (levonorgestrel and ethinyl estradiol tablets) in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with Aviane (levonorgestrel and ethinyl estradiol tablets), 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, USP (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, (19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). The inactive ingredients present are: FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. 7 light-green, inert tablets each containing: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Levonorgestrel, USP. C21H28O2 M.W. 312.45. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>13537-870-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-870-02) > 4 g in 1 TUBE (13537-870-01)</PackageDescription>
<NDC11Code>13537-0870-02</NDC11Code>
<ProductNDC>13537-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effet Parfait Rouge Amplifier</ProprietaryName>
<ProprietaryNameSuffix>Amplifying Spf 15 (rouge Grandiose) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.072</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-870-01</NDCCode>
<PackageDescription>30 g in 1 TUBE (14141-870-01) </PackageDescription>
<NDC11Code>14141-0870-01</NDC11Code>
<ProductNDC>14141-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20 Almendra 230-n</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>4; 2.4</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14783-870-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-870-02) > 4 g in 1 TUBE (14783-870-01)</PackageDescription>
<NDC11Code>14783-0870-02</NDC11Code>
<ProductNDC>14783-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effet Parfait Rouge Amplifier</ProprietaryName>
<ProprietaryNameSuffix>Amplifying Spf 15 (rouge Grandiose) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.072</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-359-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0359-01</NDC11Code>
<ProductNDC>16714-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Falmina</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090721</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-359-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0359-02</NDC11Code>
<ProductNDC>16714-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Falmina</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090721</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-359-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (16714-359-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0359-03</NDC11Code>
<ProductNDC>16714-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Falmina</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090721</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-359-04</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (16714-359-04) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0359-04</NDC11Code>
<ProductNDC>16714-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Falmina</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090721</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FALMINA is indicated for the use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of FALMINA in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alchol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch. 7 white tablets, each containing the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>21695-870-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (21695-870-20) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0870-20</NDC11Code>
<ProductNDC>21695-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021282</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-870-40</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (21695-870-40) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0870-40</NDC11Code>
<ProductNDC>21695-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021282</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-995-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 POUCH (21695-995-28) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0995-28</NDC11Code>
<ProductNDC>21695-995</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aviane</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19950824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075796</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Aviane is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with levonorgestrel and ethinyl estradiol 0.10 mg/0.02 mg tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of back-up contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are: FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate and titanium dioxide. 7 Light-green, inert tablets each contain: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (31722-944-32) / 1 KIT in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonorgetsrel And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Levonorgetsrel And Ethinyl Estradiol</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
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<LastUpdate>2023-04-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Levonorgestrel and Ethinyl Estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 2: Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The proportion of women who become pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the proportion who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>21 white active tablets each containing 0.1 mg of levonorgestrel USP, (17α)-(-)-13-ethyl-17-hydroxy-18,19, dinorpregna-4-en-20-yn-3-one, and 0.02 mg of ethinyl estradiol USP, 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17β-diol. The inactive ingredients present are cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone. 7 orange inert tablets, each containing cellulose microcrystalline, colloidal silicon dioxide, FD&C Red#40, FD&C Yellow#6, iron oxide yellow, lactose monohydrate, magnesium stearate. Levonorgestrel C 21H 28O 2 M.W. 312.5 Ethinyl Estradiol C 20H 24O 2 M.W. 296.41.</Description>
</NDC>
<NDC>
<NDCCode>35000-870-02</NDCCode>
<PackageDescription>56.6 g in 1 CONTAINER (35000-870-02)</PackageDescription>
<NDC11Code>35000-0870-02</NDC11Code>
<ProductNDC>35000-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Speed Stick</ProprietaryName>
<ProprietaryNameSuffix>Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>35000-870-03</NDCCode>
<PackageDescription>85 g in 1 CONTAINER (35000-870-03)</PackageDescription>
<NDC11Code>35000-0870-03</NDC11Code>
<ProductNDC>35000-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Speed Stick</ProprietaryName>
<ProprietaryNameSuffix>Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>36800-518-34</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (36800-518-34) </PackageDescription>
<NDC11Code>36800-0518-34</NDC11Code>
<ProductNDC>36800-518</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Pain Reliever Simple Relief</ProprietaryName>
<NonProprietaryName>Caffeine, Choline Salicylate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160906</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
<SubstanceName>CAFFEINE; CHOLINE SALICYLATE</SubstanceName>
<StrengthNumber>65; 870</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:○ headache○ minor arthritis pain○ muscle aches○ menstrual cramps○ backache. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-888-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (36800-888-08) </PackageDescription>
<NDC11Code>36800-0888-08</NDC11Code>
<ProductNDC>36800-888</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Nighttime Cold And Flu Simple Relief</ProprietaryName>
<NonProprietaryName>Choline Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160906</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
<SubstanceName>CHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>870; 50; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms. ▪ nasal congestion. ▪ minor aches and pains. ▪ runny nose. ▪ sneezing. ▪ watery eyes. ▪ sore throat. ▪ headache. ▪ temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37945-876-91</NDCCode>
<PackageDescription>1 KIT in 1 KIT (37945-876-91) * 236.558 mL in 1 BOTTLE * 1 BOTTLE in 1 BOX (37945-874-11) > 30 mL in 1 BOTTLE * 1 APPLICATOR in 1 BOX (37945-894-05) > 15 mL in 1 APPLICATOR * 1 BOTTLE, PUMP in 1 BOX (37945-870-40) > 118 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>37945-0876-91</NDC11Code>
<ProductNDC>37945-876</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kleer-plex Advanced Acne Care System</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20141103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Bio-Medical & Pharmaceutical Manufacturing Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the management of acne. Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal. Penetrates pores to eliminate most acne blemishes. Helps prevent new acne pimples.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-1380-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-1380-0) * 21 TABLET, FILM COATED in 1 KIT * 7 TABLET, FILM COATED in 1 KIT</PackageDescription>
<NDC11Code>50090-1380-00</NDC11Code>
<ProductNDC>50090-1380</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orsythia</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077099</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>Y</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ORSYTHIA® (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and levonorgestrel implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of back-up contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>21 pink active tablets each containing 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are FD&C red #40 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and vitamin E. 7 light-green inert tablets, each containing FD&C blue #2, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>50090-5580-0</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (50090-5580-0) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-5580-00</NDC11Code>
<ProductNDC>50090-5580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vienva Tm</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201088</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.</IndicationAndUsage>
<Description>Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present in the active tablet are: corn starch, crospovidone, lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch. The inactive ingredients present in the inert tablet are: corn starch, crospovidone, FD&C Red # 40 lake, D&C Yellow #10 lake, lactose anhydrous, magnesium stearate, povidone.</Description>
</NDC>
<NDC>
<NDCCode>50102-220-23</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (50102-220-23) / 1 BLISTER PACK in 1 POUCH (50102-220-21) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50102-0220-23</NDC11Code>
<ProductNDC>50102-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aubra Eq</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206886</ApplicationNumber>
<LabelerName>Afaxys Pharma, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aubra EQ is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>Each active, white tablet (21) contains 0.1 mg of levonorgestrel USP, d(-)-13β-ethyl-17α- ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol USP, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive, green tablet (7) contains the following inactive ingredients: croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow 10), lactose anhydrous, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>51660-572-86</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51660-572-86) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51660-0572-86</NDC11Code>
<ProductNDC>51660-572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delyla</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201108</ApplicationNumber>
<LabelerName>OHM LABORATORIES INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>DELYLA is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In: Hatcher RA, Trussell J Stew-art F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>Each active, white tablet (21) contains 0.1 mg of levonorgestrel, USP, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish White 014.17 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, talc, and titanium dioxide. Each inactive, yellow tablet (7) contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish Yellow 024.15 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, ferric oxide red, ferric oxide yellow, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51862-028-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (51862-028-06) / 1 KIT in 1 BLISTER PACK (51862-028-01) </PackageDescription>
<NDC11Code>51862-0028-06</NDC11Code>
<ProductNDC>51862-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lutera</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076625</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160803</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lutera is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.</IndicationAndUsage>
<Description>Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d (-)-13β-ethyl-17α-ethinyl-17β- hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl- 1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive, peach tablet (7) contains the following inactive ingredients: FD&C Yellow #6, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>51862-870-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (51862-870-01) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0870-01</NDC11Code>
<ProductNDC>51862-870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Microgestin Fe 1.5/30</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091453</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2020-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Microgestin Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Microgestin Fe 1.5/30 is progestogen-estrogen combination. Microgestin Fe 1.5/30: Each provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets and seven brown ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF,lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol,Talc, macrogol/polyethyleneglycol 3350 NF, lecithin (soya),iron oxide black ,iron oxide yellow, microcrystalline cellulose,hydroxypropyl cellulose, magnesium stearate and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>51862-870-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51862-870-02) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51862-0870-02</NDC11Code>
<ProductNDC>51862-870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Microgestin Fe 1.5/30</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091453</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2020-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Microgestin Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Microgestin Fe 1.5/30 is progestogen-estrogen combination. Microgestin Fe 1.5/30: Each provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets and seven brown ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF,lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol,Talc, macrogol/polyethyleneglycol 3350 NF, lecithin (soya),iron oxide black ,iron oxide yellow, microcrystalline cellulose,hydroxypropyl cellulose, magnesium stearate and crospovidone.</Description>
</NDC>
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