{
"NDC": [
{
"NDCCode": "65197-296-24",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0296-24",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230215",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230501",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-230-24",
"PackageDescription": "1 BOTTLE in 1 BOX (65197-230-24) / 24 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "65197-0230-24",
"ProductNDC": "65197-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Emetrol Multi Symptom Upset Stomach Relief",
"NonProprietaryName": "Childrens Emetrol Multi-symptom Upset Stomach Relief",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20260615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "CALCIUM CATION; DIMETHICONE",
"StrengthNumber": "400; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn, 3 sour stomach, 4 upset stomach associated with these symptoms, 5 pressure and bloating commonly, 6 referred to as gas, 7 overindulgence in food."
},
{
"NDCCode": "65197-297-24",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (65197-297-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0297-24",
"ProductNDC": "65197-297",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-296-08",
"PackageDescription": "1 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0296-08",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230215",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230215",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-296-12",
"PackageDescription": "1 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "65197-0296-12",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230215",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230215",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-296-16",
"PackageDescription": "2 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0296-16",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230215",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230215",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "65197-296-32",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (65197-296-32) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0296-32",
"ProductNDC": "65197-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bonine",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230215",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230601",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness associated with motion sickness."
},
{
"NDCCode": "36000-296-24",
"PackageDescription": "150 mL in 1 BAG (36000-296-24) ",
"NDC11Code": "36000-0296-24",
"ProductNDC": "36000-296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130701",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091397",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190415",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ∙ ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. The appearance of Levofloxacin Injection may range from a clear yellow to a clear greenish-yellow solution. This does not adversely affect product potency. Levofloxacin Injection in 5% Dextrose (Premix) in Single-Use Flexible Containers is a sterile, preservative-free aqueous solution of levofloxacin with pH ranging from 3.8 to 5.8. This is a dilute, non-pyrogenic, nearly isotonic premixed solution that contains levofloxacin in 5% Dextrose (D W). Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH. The flexible container is fabricated from specially formulated non-plasticized, thermoplastic copolyester (CR3). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "54473-296-24",
"PackageDescription": "71 mL in 1 BOTTLE (54473-296-24) ",
"NDC11Code": "54473-0296-24",
"ProductNDC": "54473-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clear Defense",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100409",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Melaleuca, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "150.97",
"StrengthUnit": "g/266mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 to reduce bacteria on the skin, 2 recommended for repeated use ."
},
{
"NDCCode": "60289-296-24",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (60289-296-24) / 50 mL in 1 BOTTLE, GLASS",
"NDC11Code": "60289-0296-24",
"ProductNDC": "60289-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lumior",
"ProprietaryNameSuffix": "Men Facial Moisturizer Broad Spectrum Spf 15",
"NonProprietaryName": "Avobenzone, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201001",
"EndMarketingDate": "20251230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "AHAVA Dead Sea Laboratories Ltd",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 50; 27.4",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201001",
"EndMarketingDatePackage": "20251230",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "63868-296-24",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (63868-296-24) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "63868-0296-24",
"ProductNDC": "63868-296",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laxative Pills",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "QUALITY CHOICE (Chain Drug Marketing Association)",
"SubstanceName": "SENNOSIDES",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180831",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "73597-026-10",
"PackageDescription": "24 BOTTLE in 1 CARTON (73597-026-10) / 296 mL in 1 BOTTLE",
"NDC11Code": "73597-0026-10",
"ProductNDC": "73597-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Royal Dandruff Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230315",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Mission Series Inc. dba Prestige Beauty Care",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230315",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect the scalp's natural moisture balance and gives you great looking hair."
},
{
"NDCCode": "77335-001-24",
"PackageDescription": ".296 L in 1 BOTTLE (77335-001-24) ",
"NDC11Code": "77335-0001-24",
"ProductNDC": "77335-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "W.r.lulus Rinse-free Hand Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Lulus import and export co., ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73.7",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitize to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "65197-300-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0300-10",
"ProductNDC": "65197-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gelusil",
"NonProprietaryName": "Alumina, Magnesia, Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20080924",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; SILICON DIOXIDE",
"StrengthNumber": "200; 200; 24; 1",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080924",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: 1 Heartburn, 2 Sour stomach, 3 Acid indigestion, 4 Bloating, pressure and discomfort commonly referred to as gas."
},
{
"NDCCode": "65197-300-11",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11) ",
"NDC11Code": "65197-0300-11",
"ProductNDC": "65197-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gelusil",
"NonProprietaryName": "Alumina, Magnesia, Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20080924",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; SILICON DIOXIDE",
"StrengthNumber": "200; 200; 24; 1",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: 1 Heartburn, 2 Sour stomach, 3 Acid indigestion, 4 Bloating, pressure and discomfort commonly referred to as gas."
},
{
"NDCCode": "65197-300-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (65197-300-20) > 10 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "65197-0300-20",
"ProductNDC": "65197-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gelusil",
"NonProprietaryName": "Aluminum Hydroxide Dried Gel And Magnesium Hydroxide And Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "WellSpring Pharmaceutical Corporation",
"SubstanceName": "ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE; SILICON DIOXIDE",
"StrengthNumber": "200; 24; 200; 1",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0093-4000-62",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) ",
"NDC11Code": "00093-4000-62",
"ProductNDC": "0093-4000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vestura",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20210302",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078833",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210302",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 peach inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40. The peach inert uncoated tablets contain lactose anhydrous, microcrystalline cellulose, FD&C Yellow #6, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows."
},
{
"NDCCode": "0378-7299-53",
"PackageDescription": "3 POUCH in 1 CARTON (0378-7299-53) / 1 BLISTER PACK in 1 POUCH (0378-7299-85) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00378-7299-53",
"ProductNDC": "0378-7299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Drospirenone And Ethinyl Estradiol",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180423",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202594",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180423",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Drospirenone and ethinyl estradiol tablets USP, 3 mg/0.02 mg provide an oral contraceptive regimen consisting of 24 yellow active uncoated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 green inert uncoated tablets. The inactive ingredients in the yellow tablets are crospovidone, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, maize starch, and povidone. The green inert uncoated tablets contain FD&C Blue No. 1, lactose monohydrate, magnesium stearate, polacrillin potassium, and yellow oxide of iron. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11, 12,13,14,15,15a,16-hexadecahydro- 10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows. Contains color additives including FD&C Yellow No. 5 (tartrazine). Meets USP Dissolution Test 3."
},
{
"NDCCode": "0480-3472-24",
"PackageDescription": "1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "00480-3472-24",
"ProductNDC": "0480-3472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amethyst",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079218",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "LEVONORGESTREL; ETHINYL ESTRADIOL",
"StrengthNumber": "90; 20",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Amethyst (levonorgestrel and ethinyl estradiol tablets) 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 for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend 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. .",
"Description": "Twenty-eight (28) white tablets each containing 90 mcg of levonorgestrel, USP (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, USP (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Levonorgestrel, USPC21H28O2 M.W. 312.45. Ethinyl Estradiol, USPC20H24O2 M.W. 296.40."
},
{
"NDCCode": "0480-3493-16",
"PackageDescription": "6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22) ",
"NDC11Code": "00480-3493-16",
"ProductNDC": "0480-3493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cryselle",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075840",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The light green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2 MW: 296.40."
},
{
"NDCCode": "0480-4000-62",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0480-4000-62) / 1 KIT in 1 BLISTER PACK (0480-4000-28) * 24 TABLET in 1 BLISTER PACK (0480-3629-11) * 4 TABLET in 1 BLISTER PACK (0480-7892-22) ",
"NDC11Code": "00480-4000-62",
"ProductNDC": "0480-4000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vestura",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20241106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078833",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241106",
"SamplePackage": "N",
"IndicationAndUsage": "Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 white inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40 Aluminum Lake. The white inert uncoated tablets contain lactose anhydrous, hypromellose 2208, microcrystalline cellulose, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows."
},
{
"NDCCode": "0555-9025-42",
"PackageDescription": "3 POUCH in 1 CARTON (0555-9025-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "00555-9025-42",
"ProductNDC": "0555-9025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Junel",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076380",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1; 20",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030918",
"SamplePackage": "N",
"IndicationAndUsage": "Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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": "Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0555-9026-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9026-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9026-58",
"ProductNDC": "0555-9026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Junel",
"ProprietaryNameSuffix": "Fe 28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20030918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076081",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030918",
"SamplePackage": "N",
"IndicationAndUsage": "Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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": "Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0555-9027-42",
"PackageDescription": "3 POUCH in 1 CARTON (0555-9027-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "00555-9027-42",
"ProductNDC": "0555-9027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Junel",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076381",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1.5; 30",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030918",
"SamplePackage": "N",
"IndicationAndUsage": "Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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": "Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0555-9028-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9028-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9028-58",
"ProductNDC": "0555-9028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Junel",
"ProprietaryNameSuffix": "Fe 28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20030918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076064",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030918",
"SamplePackage": "N",
"IndicationAndUsage": "Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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": "Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0555-9032-70",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0555-9032-70) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9032-70",
"ProductNDC": "0555-9032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-legest Fe",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20071026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076105",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2023-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071026",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tri-Legest® Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest® Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment. Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6).",
"Description": "Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tri-Legest® Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light pink tablet contains 1 mg norethindrone acetate [(17α)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol] Each light pink tablet contains the following inactive ingredients: calcium stearate, FD&C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: calcium stearate, D&C yellow no.10 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light blue tablet contains the following inactive ingredients: calcium stearate, FD&C blue no. 2 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each brown tablet contains crospovidone, ferrous fumarate, hydrogenated vegetable oil, and microcrystalline cellulose. The structural formulas are as follows. Norethindrone Acetate Ethinyl Estradiol. C22H28O3 Molecular Weight: 340.46 C20H24O2 Molecular Weight: 296.40. Each Tri-Legest® Fe tablet dispenser contains five light pink tablets, seven light yellow tablets, nine light blue tablets, and seven brown tablets. These tablets are to be taken in the following order: one light pink tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light blue tablet each day for nine days, and then one brown tablet each day for seven days."
},
{
"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": "0904-6787-44",
"PackageDescription": "296 mL in 1 BOTTLE, PLASTIC (0904-6787-44) ",
"NDC11Code": "00904-6787-44",
"ProductNDC": "0904-6787",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Saline Laxative",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180218",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "10237-258-10",
"PackageDescription": "296 mL in 1 BOTTLE, PLASTIC (10237-258-10) ",
"NDC11Code": "10237-0258-10",
"ProductNDC": "10237-258",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therabreath Healthy Gums",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20230213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": ".01",
"StrengthUnit": "mg/20mL",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251223",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent gingivitis, an early form of gum disease bleeding gums. Helps control plaque that leads to gingivitis bleeding gums."
},
{
"NDCCode": "21695-685-28",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (21695-685-28) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "21695-0685-28",
"ProductNDC": "21695-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tilia Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076629",
"LabelerName": "Rebel Distributors Corp",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received norethindrone acetate and ethinyl estradiol tablets and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
"Description": "Tilia Fe is a graduated estrophasic providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and 7 ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white tablet contains 1 mg norethindrone acetate, (17α) 17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one, and 20 mcg ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. Each light-green tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The light-green tablets also contain D&C Yellow #10 and FD&C Blue #1. Each green tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The green tablets also contain D&C Yellow #10 and FD&C Blue #1. The structural formulas are as follows. Norethindrone Acetate C22H28O3 M.W. 340.46 Ethinyl Es tradiol C20H24O2 M.W. 296.4. Each inactive, brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate and sodium starch glycolate. Ferrous fumarate tablets are not USP for dissolution and assay. Each dispenser of Tilia Fe, contains 5 white tablets, 7 light-green tablets, 9 green tablets, and 7 brown tablets. These tablets are to be taken in the following order: one white tablet each day for five days, then one light-green tablet each day for seven days, followed by one green tablet each day for nine days, and then one brown tablet each day for seven days."
}
]
}
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<NDC>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bonine</ProprietaryName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
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<NDC>
<NDCCode>65197-230-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (65197-230-24) / 24 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>65197-0230-24</NDC11Code>
<ProductNDC>65197-230</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Emetrol Multi Symptom Upset Stomach Relief</ProprietaryName>
<NonProprietaryName>Childrens Emetrol Multi-symptom Upset Stomach Relief</NonProprietaryName>
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<StartMarketingDate>20260615</StartMarketingDate>
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<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260615</StartMarketingDatePackage>
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<NDCCode>65197-297-24</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (65197-297-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65197-0297-24</NDC11Code>
<ProductNDC>65197-297</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bonine</ProprietaryName>
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<DosageFormName>TABLET, CHEWABLE</DosageFormName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness associated with motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65197-296-08</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65197-0296-08</NDC11Code>
<ProductNDC>65197-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bonine</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230215</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness associated with motion sickness.</IndicationAndUsage>
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<NDC>
<NDCCode>65197-296-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>65197-0296-12</NDC11Code>
<ProductNDC>65197-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bonine</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230215</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230215</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness associated with motion sickness.</IndicationAndUsage>
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<NDC>
<NDCCode>65197-296-16</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65197-0296-16</NDC11Code>
<ProductNDC>65197-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bonine</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
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<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230215</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness associated with motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65197-296-32</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (65197-296-32) / 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65197-0296-32</NDC11Code>
<ProductNDC>65197-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bonine</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230215</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness associated with motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36000-296-24</NDCCode>
<PackageDescription>150 mL in 1 BAG (36000-296-24) </PackageDescription>
<NDC11Code>36000-0296-24</NDC11Code>
<ProductNDC>36000-296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091397</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ∙ ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. The appearance of Levofloxacin Injection may range from a clear yellow to a clear greenish-yellow solution. This does not adversely affect product potency. Levofloxacin Injection in 5% Dextrose (Premix) in Single-Use Flexible Containers is a sterile, preservative-free aqueous solution of levofloxacin with pH ranging from 3.8 to 5.8. This is a dilute, non-pyrogenic, nearly isotonic premixed solution that contains levofloxacin in 5% Dextrose (D W). Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH. The flexible container is fabricated from specially formulated non-plasticized, thermoplastic copolyester (CR3). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>54473-296-24</NDCCode>
<PackageDescription>71 mL in 1 BOTTLE (54473-296-24) </PackageDescription>
<NDC11Code>54473-0296-24</NDC11Code>
<ProductNDC>54473-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clear Defense</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Melaleuca, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>150.97</StrengthNumber>
<StrengthUnit>g/266mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 to reduce bacteria on the skin, 2 recommended for repeated use .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60289-296-24</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (60289-296-24) / 50 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>60289-0296-24</NDC11Code>
<ProductNDC>60289-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lumior</ProprietaryName>
<ProprietaryNameSuffix>Men Facial Moisturizer Broad Spectrum Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<EndMarketingDate>20251230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>AHAVA Dead Sea Laboratories Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 50; 27.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<EndMarketingDatePackage>20251230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63868-296-24</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (63868-296-24) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63868-0296-24</NDC11Code>
<ProductNDC>63868-296</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laxative Pills</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>QUALITY CHOICE (Chain Drug Marketing Association)</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73597-026-10</NDCCode>
<PackageDescription>24 BOTTLE in 1 CARTON (73597-026-10) / 296 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>73597-0026-10</NDC11Code>
<ProductNDC>73597-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Royal Dandruff Dry Scalp Care</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Mission Series Inc. dba Prestige Beauty Care</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect the scalp's natural moisture balance and gives you great looking hair.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77335-001-24</NDCCode>
<PackageDescription>.296 L in 1 BOTTLE (77335-001-24) </PackageDescription>
<NDC11Code>77335-0001-24</NDC11Code>
<ProductNDC>77335-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>W.r.lulus Rinse-free Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Lulus import and export co., ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>73.7</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitize to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65197-300-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65197-0300-10</NDC11Code>
<ProductNDC>65197-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gelusil</ProprietaryName>
<NonProprietaryName>Alumina, Magnesia, Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080924</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>200; 200; 24; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: 1 Heartburn, 2 Sour stomach, 3 Acid indigestion, 4 Bloating, pressure and discomfort commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65197-300-11</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11) </PackageDescription>
<NDC11Code>65197-0300-11</NDC11Code>
<ProductNDC>65197-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gelusil</ProprietaryName>
<NonProprietaryName>Alumina, Magnesia, Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080924</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>200; 200; 24; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: 1 Heartburn, 2 Sour stomach, 3 Acid indigestion, 4 Bloating, pressure and discomfort commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65197-300-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (65197-300-20) > 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65197-0300-20</NDC11Code>
<ProductNDC>65197-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gelusil</ProprietaryName>
<NonProprietaryName>Aluminum Hydroxide Dried Gel And Magnesium Hydroxide And Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>200; 24; 200; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0093-4000-62</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) </PackageDescription>
<NDC11Code>00093-4000-62</NDC11Code>
<ProductNDC>0093-4000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vestura</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210302</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078833</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210302</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 peach inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40. The peach inert uncoated tablets contain lactose anhydrous, microcrystalline cellulose, FD&C Yellow #6, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>0378-7299-53</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (0378-7299-53) / 1 BLISTER PACK in 1 POUCH (0378-7299-85) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00378-7299-53</NDC11Code>
<ProductNDC>0378-7299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Drospirenone And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180423</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202594</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180423</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Drospirenone and ethinyl estradiol tablets USP, 3 mg/0.02 mg provide an oral contraceptive regimen consisting of 24 yellow active uncoated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 green inert uncoated tablets. The inactive ingredients in the yellow tablets are crospovidone, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, maize starch, and povidone. The green inert uncoated tablets contain FD&C Blue No. 1, lactose monohydrate, magnesium stearate, polacrillin potassium, and yellow oxide of iron. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11, 12,13,14,15,15a,16-hexadecahydro- 10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows. Contains color additives including FD&C Yellow No. 5 (tartrazine). Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>0480-3472-24</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00480-3472-24</NDC11Code>
<ProductNDC>0480-3472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amethyst</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079218</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>90; 20</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amethyst (levonorgestrel and ethinyl estradiol tablets) 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 for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend 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. .</IndicationAndUsage>
<Description>Twenty-eight (28) white tablets each containing 90 mcg of levonorgestrel, USP (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, USP (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Levonorgestrel, USPC21H28O2 M.W. 312.45. Ethinyl Estradiol, USPC20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0480-3493-16</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22) </PackageDescription>
<NDC11Code>00480-3493-16</NDC11Code>
<ProductNDC>0480-3493</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cryselle</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075840</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The light green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2 MW: 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0480-4000-62</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0480-4000-62) / 1 KIT in 1 BLISTER PACK (0480-4000-28) * 24 TABLET in 1 BLISTER PACK (0480-3629-11) * 4 TABLET in 1 BLISTER PACK (0480-7892-22) </PackageDescription>
<NDC11Code>00480-4000-62</NDC11Code>
<ProductNDC>0480-4000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vestura</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20241106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078833</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vestura is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Vestura® (drospirenone and ethinyl estradiol) tablets, USP provides an oral contraceptive regimen consisting of 24 pink active uncoated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP (stabilized using vitamin E and an enhanced processing technique) and 4 white inert uncoated tablets. The inactive ingredients in the pink tablets are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, and FD&C Red #40 Aluminum Lake. The white inert uncoated tablets contain lactose anhydrous, hypromellose 2208, microcrystalline cellulose, and magnesium stearate. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>0555-9025-42</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (0555-9025-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9025-42</NDC11Code>
<ProductNDC>0555-9025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Junel</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076380</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1; 20</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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>Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0555-9026-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9026-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9026-58</NDC11Code>
<ProductNDC>0555-9026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Junel</ProprietaryName>
<ProprietaryNameSuffix>Fe 28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076081</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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>Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0555-9027-42</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (0555-9027-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9027-42</NDC11Code>
<ProductNDC>0555-9027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Junel</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076381</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1.5; 30</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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>Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0555-9028-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9028-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9028-58</NDC11Code>
<ProductNDC>0555-9028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Junel</ProprietaryName>
<ProprietaryNameSuffix>Fe 28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20030918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076064</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of 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>Junel® 21 and Junel® Fe 28 are progestogen-estrogen combinations. Junel® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0555-9032-70</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0555-9032-70) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9032-70</NDC11Code>
<ProductNDC>0555-9032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-legest Fe</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20071026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076105</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tri-Legest® Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest® Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment. Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6).</IndicationAndUsage>
<Description>Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tri-Legest® Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light pink tablet contains 1 mg norethindrone acetate [(17α)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol] Each light pink tablet contains the following inactive ingredients: calcium stearate, FD&C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: calcium stearate, D&C yellow no.10 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light blue tablet contains the following inactive ingredients: calcium stearate, FD&C blue no. 2 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each brown tablet contains crospovidone, ferrous fumarate, hydrogenated vegetable oil, and microcrystalline cellulose. The structural formulas are as follows. Norethindrone Acetate Ethinyl Estradiol. C22H28O3 Molecular Weight: 340.46 C20H24O2 Molecular Weight: 296.40. Each Tri-Legest® Fe tablet dispenser contains five light pink tablets, seven light yellow tablets, nine light blue tablets, and seven brown tablets. These tablets are to be taken in the following order: one light pink tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light blue tablet each day for nine days, and then one brown tablet each day for seven days.</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>0904-6787-44</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, PLASTIC (0904-6787-44) </PackageDescription>
<NDC11Code>00904-6787-44</NDC11Code>
<ProductNDC>0904-6787</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Saline Laxative</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-258-10</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, PLASTIC (10237-258-10) </PackageDescription>
<NDC11Code>10237-0258-10</NDC11Code>
<ProductNDC>10237-258</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therabreath Healthy Gums</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent gingivitis, an early form of gum disease bleeding gums. Helps control plaque that leads to gingivitis bleeding gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-685-28</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (21695-685-28) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0685-28</NDC11Code>
<ProductNDC>21695-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tilia Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076629</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received norethindrone acetate and ethinyl estradiol tablets and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.</IndicationAndUsage>
<Description>Tilia Fe is a graduated estrophasic providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and 7 ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white tablet contains 1 mg norethindrone acetate, (17α) 17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one, and 20 mcg ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. Each light-green tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The light-green tablets also contain D&C Yellow #10 and FD&C Blue #1. Each green tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The green tablets also contain D&C Yellow #10 and FD&C Blue #1. The structural formulas are as follows. Norethindrone Acetate C22H28O3 M.W. 340.46 Ethinyl Es tradiol C20H24O2 M.W. 296.4. Each inactive, brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate and sodium starch glycolate. Ferrous fumarate tablets are not USP for dissolution and assay. Each dispenser of Tilia Fe, contains 5 white tablets, 7 light-green tablets, 9 green tablets, and 7 brown tablets. These tablets are to be taken in the following order: one white tablet each day for five days, then one light-green tablet each day for seven days, followed by one green tablet each day for nine days, and then one brown tablet each day for seven days.</Description>
</NDC>
</NDCList>