{
"NDC": [
{
"NDCCode": "46122-384-51",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-384-51) > 40 mg in 1 BLISTER PACK",
"NDC11Code": "46122-0384-51",
"ProductNDC": "46122-384",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Gentle Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20150213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "AmerisourceBergen Drug Corp",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/2000mg",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20151116",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional constipation and irregularity. -This product generally produces bowel movement in 15 minutes to 1 hour."
},
{
"NDCCode": "79260-384-51",
"PackageDescription": "1000 mL in 1 BOTTLE (79260-384-51) ",
"NDC11Code": "79260-0384-51",
"ProductNDC": "79260-384",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aris Hand Sanitizer With Aloe Vera",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "WINNER MANUFACTURING",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200706",
"SamplePackage": "N",
"IndicationAndUsage": "▪ Hand sanitizer to help reduce bacteria on the skin that could cause disease. ▪ Recommended for repeated use."
},
{
"NDCCode": "46122-535-51",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (46122-535-51) / 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "46122-0535-51",
"ProductNDC": "46122-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness Relief",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020624",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020624",
"SamplePackage": "N",
"IndicationAndUsage": "for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness."
},
{
"NDCCode": "46122-608-51",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-608-51) / 40 mg in 1 BLISTER PACK",
"NDC11Code": "46122-0608-51",
"ProductNDC": "46122-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Gentle Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20190626",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "AmerisourceBergen Drug Corp",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/2000mg",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190626",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional constipation and irregularity. -This product generally produces bowel movement in 15 minutes to 1 hour."
},
{
"NDCCode": "46122-750-51",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-750-51) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "46122-0750-51",
"ProductNDC": "46122-750",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209254",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230811",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "46122-763-51",
"PackageDescription": "32 BLISTER PACK in 1 CARTON (46122-763-51) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "46122-0763-51",
"ProductNDC": "46122-763",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Sleep Aid",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040167",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240405",
"EndMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "helps to reduce difficulty in falling asleep."
},
{
"NDCCode": "46122-774-51",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-774-51) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "46122-0774-51",
"ProductNDC": "46122-774",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness Relief",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20240319",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240319",
"SamplePackage": "N",
"IndicationAndUsage": "for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness."
},
{
"NDCCode": "46122-798-51",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-798-51) / 10 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "46122-0798-51",
"ProductNDC": "46122-798",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy",
"ProprietaryNameSuffix": "Childrens Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250623",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250623",
"SamplePackage": "N",
"IndicationAndUsage": "▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.▪runny nose▪itchy, watery eyes▪sneezing▪itching of the nose or throat."
},
{
"NDCCode": "46122-828-51",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-828-51) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "46122-0828-51",
"ProductNDC": "46122-828",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20260309",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes."
},
{
"NDCCode": "46122-829-51",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-829-51) / 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "46122-0829-51",
"ProductNDC": "46122-829",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260504",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat."
},
{
"NDCCode": "0093-8073-16",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0093-8073-16) / 1 KIT in 1 BLISTER PACK (0093-8073-28) ",
"NDC11Code": "00093-8073-16",
"ProductNDC": "0093-8073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kelnor 1/50",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180301",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072723",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180301",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Kelnor 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Kelnor 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Kelnor® 1/50 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP). Each pink tablet contains 1 mg of ethynodiol diacetate, USP and 50 mcg of ethinyl estradiol, USP and the inactive ingredients include anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Kelnor 1/50 package is a placebo containing no active ingredients, and the inactive ingredients include anhydrous lactose, magnesium stearate and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. Therapeutic class: Oral contraceptive."
},
{
"NDCCode": "0338-0202-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-0202-06) / 1000 mL in 1 BAG (0338-0202-01) ",
"NDC11Code": "00338-0202-06",
"ProductNDC": "0338-0202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0206-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-0206-04) / 2000 mL in 1 BAG (0338-0206-01) ",
"NDC11Code": "00338-0206-04",
"ProductNDC": "0338-0206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0210-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-0210-06) / 1000 mL in 1 BAG (0338-0210-01) ",
"NDC11Code": "00338-0210-06",
"ProductNDC": "0338-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0214-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-0214-04) / 2000 mL in 1 BAG (0338-0214-01) ",
"NDC11Code": "00338-0214-04",
"ProductNDC": "0338-0214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0555-0606-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0606-02) ",
"NDC11Code": "00555-0606-02",
"ProductNDC": "0555-0606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074621",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19961025",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate tablets, USP are a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17α-acetyloxy-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. The structural formula is represented as follows. C24H32O4 M.W. 384.51. Megestrol acetate tablets, USP are supplied as tablets for oral administration containing 20 mg or 40 mg megestrol acetate. Inactive Ingredients: Anhydrous lactose, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "0555-0607-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0607-02) ",
"NDC11Code": "00555-0607-02",
"ProductNDC": "0555-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074621",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951130",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate tablets, USP are a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17α-acetyloxy-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. The structural formula is represented as follows. C24H32O4 M.W. 384.51. Megestrol acetate tablets, USP are supplied as tablets for oral administration containing 20 mg or 40 mg megestrol acetate. Inactive Ingredients: Anhydrous lactose, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "0555-9064-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9064-58) > 1 BLISTER PACK in 1 POUCH (0555-9064-79) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9064-58",
"ProductNDC": "0555-9064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kelnor 1/35",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20050620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076785",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2022-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050620",
"SamplePackage": "N",
"IndicationAndUsage": "Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate 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. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. 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. 3. 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. 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 Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.",
"Description": "Kelnor® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0904-7236-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7236-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7236-61",
"ProductNDC": "0904-7236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072423",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220601",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4 and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch."
},
{
"NDCCode": "16590-898-08",
"PackageDescription": "240 mL in 1 BOTTLE, PLASTIC (16590-898-08)",
"NDC11Code": "16590-0898-08",
"ProductNDC": "16590-898",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestol",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20020215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075997",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Megestrol Acetate Oral Suspension USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H3204 and the structural formula is represented as follows. Megestrol Acetate Oral Suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol Acetate Oral Suspension contains the following inactive ingredients: citric acid, lemon-lime flavor, microcrystalline cellulose/carboxymethylcellulose, purified water, sodium benzoate, sodium citrate, and sucrose. The suspension meets the requirements of USP Dissolution Test 3 in the USP monograph for Megestrol Acetate Oral Suspension, USP."
},
{
"NDCCode": "49884-289-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-289-01) ",
"NDC11Code": "49884-0289-01",
"ProductNDC": "49884-289",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880808",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072422",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880808",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch."
},
{
"NDCCode": "49884-290-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (49884-290-01) ",
"NDC11Code": "49884-0290-01",
"ProductNDC": "49884-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880808",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072423",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880808",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch."
},
{
"NDCCode": "49884-290-04",
"PackageDescription": "250 TABLET in 1 BOTTLE (49884-290-04) ",
"NDC11Code": "49884-0290-04",
"ProductNDC": "49884-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880808",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072423",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880808",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch."
},
{
"NDCCode": "49884-290-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (49884-290-05) ",
"NDC11Code": "49884-0290-05",
"ProductNDC": "49884-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880808",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072423",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880808",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch."
},
{
"NDCCode": "50090-2191-0",
"PackageDescription": "1 KIT in 1 KIT (50090-2191-0) ",
"NDC11Code": "50090-2191-00",
"ProductNDC": "50090-2191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kelnor 1/35",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20050620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076785",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2023-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate 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. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. 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. 3. 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. 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 Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.",
"Description": "Kelnor® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "50383-859-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-859-24) > 240 mL in 1 BOTTLE",
"NDC11Code": "50383-0859-24",
"ProductNDC": "50383-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203960",
"LabelerName": "Akorn",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170609",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).",
"Description": "Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17α-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.51. The empirical formula is C24H32O4 and the structural formula is represented as follows. megestrol acetate, USP. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: citric acid, natural and artificial lemon-lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
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"ProductNDC": "53002-1591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zovia 1/35",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076785",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Zovia® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "53002-1591-3",
"PackageDescription": "3 BLISTER PACK in 1 PACKAGE (53002-1591-3) > 1 KIT in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zovia 1/35",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
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"SamplePackage": "N",
"IndicationAndUsage": "Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Zovia® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "53002-1591-6",
"PackageDescription": "6 BLISTER PACK in 1 PACKAGE (53002-1591-6) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "53002-1591-06",
"ProductNDC": "53002-1591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zovia 1/35",
"NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076785",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Zovia® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "53808-0614-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-0614-1)",
"NDC11Code": "53808-0614-01",
"ProductNDC": "53808-0614",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074458",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.",
"Description": "Megestrol acetate, is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The empirical formula is C24 H32O4 and the structural formula is represented as follows. Megestrol acetate tablets are supplied for oral administration containing 20 mg or 40 mg megestrol acetate and the following inactive ingredients: acacia, colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and starch (corn)."
}
]
}
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<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.▪runny nose▪itchy, watery eyes▪sneezing▪itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46122-828-51</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (46122-828-51) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0828-51</NDC11Code>
<ProductNDC>46122-828</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260309</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>AMERISOURCE BERGEN</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46122-829-51</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (46122-829-51) / 12 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0829-51</NDC11Code>
<ProductNDC>46122-829</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260504</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>AMERISOURCE BERGEN</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0093-8073-16</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0093-8073-16) / 1 KIT in 1 BLISTER PACK (0093-8073-28) </PackageDescription>
<NDC11Code>00093-8073-16</NDC11Code>
<ProductNDC>0093-8073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kelnor 1/50</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180301</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072723</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kelnor 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Kelnor 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Kelnor® 1/50 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP). Each pink tablet contains 1 mg of ethynodiol diacetate, USP and 50 mcg of ethinyl estradiol, USP and the inactive ingredients include anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Kelnor 1/50 package is a placebo containing no active ingredients, and the inactive ingredients include anhydrous lactose, magnesium stearate and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. Therapeutic class: Oral contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>0338-0202-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0202-06) / 1000 mL in 1 BAG (0338-0202-01) </PackageDescription>
<NDC11Code>00338-0202-06</NDC11Code>
<ProductNDC>0338-0202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0206-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0206-04) / 2000 mL in 1 BAG (0338-0206-01) </PackageDescription>
<NDC11Code>00338-0206-04</NDC11Code>
<ProductNDC>0338-0206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0210-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0210-06) / 1000 mL in 1 BAG (0338-0210-01) </PackageDescription>
<NDC11Code>00338-0210-06</NDC11Code>
<ProductNDC>0338-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0214-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0214-04) / 2000 mL in 1 BAG (0338-0214-01) </PackageDescription>
<NDC11Code>00338-0214-04</NDC11Code>
<ProductNDC>0338-0214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0555-0606-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0606-02) </PackageDescription>
<NDC11Code>00555-0606-02</NDC11Code>
<ProductNDC>0555-0606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074621</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate tablets, USP are a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17α-acetyloxy-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. The structural formula is represented as follows. C24H32O4 M.W. 384.51. Megestrol acetate tablets, USP are supplied as tablets for oral administration containing 20 mg or 40 mg megestrol acetate. Inactive Ingredients: Anhydrous lactose, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0555-0607-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0607-02) </PackageDescription>
<NDC11Code>00555-0607-02</NDC11Code>
<ProductNDC>0555-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074621</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-21</LastUpdate>
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<StartMarketingDatePackage>19951130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate tablets, USP are a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17α-acetyloxy-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. The structural formula is represented as follows. C24H32O4 M.W. 384.51. Megestrol acetate tablets, USP are supplied as tablets for oral administration containing 20 mg or 40 mg megestrol acetate. Inactive Ingredients: Anhydrous lactose, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<PackageDescription>6 POUCH in 1 CARTON (0555-9064-58) > 1 BLISTER PACK in 1 POUCH (0555-9064-79) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9064-58</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kelnor 1/35</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<IndicationAndUsage>Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate 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. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. 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. 3. 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. 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 Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.</IndicationAndUsage>
<Description>Kelnor® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
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<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7236-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>0904-7236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072423</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
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<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
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<LastUpdate>2025-09-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4 and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>16590-898-08</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE, PLASTIC (16590-898-08)</PackageDescription>
<NDC11Code>16590-0898-08</NDC11Code>
<ProductNDC>16590-898</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestol</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075997</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Megestrol Acetate Oral Suspension USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H3204 and the structural formula is represented as follows. Megestrol Acetate Oral Suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol Acetate Oral Suspension contains the following inactive ingredients: citric acid, lemon-lime flavor, microcrystalline cellulose/carboxymethylcellulose, purified water, sodium benzoate, sodium citrate, and sucrose. The suspension meets the requirements of USP Dissolution Test 3 in the USP monograph for Megestrol Acetate Oral Suspension, USP.</Description>
</NDC>
<NDC>
<NDCCode>49884-289-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-289-01) </PackageDescription>
<NDC11Code>49884-0289-01</NDC11Code>
<ProductNDC>49884-289</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880808</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072422</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880808</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>49884-290-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-290-01) </PackageDescription>
<NDC11Code>49884-0290-01</NDC11Code>
<ProductNDC>49884-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19880808</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072423</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880808</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>49884-290-04</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (49884-290-04) </PackageDescription>
<NDC11Code>49884-0290-04</NDC11Code>
<ProductNDC>49884-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880808</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072423</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880808</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch.</Description>
</NDC>
<NDC>
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<NDC11Code>49884-0290-05</NDC11Code>
<ProductNDC>49884-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072423</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880808</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C24H32O4and the structural formula is represented as follows. Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch.</Description>
</NDC>
<NDC>
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<PackageDescription>1 KIT in 1 KIT (50090-2191-0) </PackageDescription>
<NDC11Code>50090-2191-00</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kelnor 1/35</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20050620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076785</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate 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. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. 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. 3. 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. 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 Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.</IndicationAndUsage>
<Description>Kelnor® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>50383-859-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-859-24) > 240 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0859-24</NDC11Code>
<ProductNDC>50383-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203960</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).</IndicationAndUsage>
<Description>Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17α-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.51. The empirical formula is C24H32O4 and the structural formula is represented as follows. megestrol acetate, USP. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: citric acid, natural and artificial lemon-lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>53002-1591-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (53002-1591-1) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1591-01</NDC11Code>
<ProductNDC>53002-1591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zovia 1/35</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076785</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Zovia® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>53002-1591-3</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 PACKAGE (53002-1591-3) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1591-03</NDC11Code>
<ProductNDC>53002-1591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zovia 1/35</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076785</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Zovia® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>53002-1591-6</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 PACKAGE (53002-1591-6) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1591-06</NDC11Code>
<ProductNDC>53002-1591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zovia 1/35</ProprietaryName>
<NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076785</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Zovia® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows. Ethynodiol Diacetate, USP. C24H32O4 M.W. 384.51. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>53808-0614-1</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (53808-0614-1)</PackageDescription>
<NDC11Code>53808-0614-01</NDC11Code>
<ProductNDC>53808-0614</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074458</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.</IndicationAndUsage>
<Description>Megestrol acetate, is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The empirical formula is C24 H32O4 and the structural formula is represented as follows. Megestrol acetate tablets are supplied for oral administration containing 20 mg or 40 mg megestrol acetate and the following inactive ingredients: acacia, colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and starch (corn).</Description>
</NDC>
</NDCList>