{
"NDC": [
{
"NDCCode": "58657-860-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) ",
"NDC11Code": "58657-0860-25",
"ProductNDC": "58657-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209781",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] ."
},
{
"NDCCode": "58657-851-26",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (58657-851-26) / 1 mL in 1 VIAL, SINGLE-DOSE (58657-851-25) ",
"NDC11Code": "58657-0851-26",
"ProductNDC": "58657-851",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218412",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260201",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
"Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5."
},
{
"NDCCode": "58657-860-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) ",
"NDC11Code": "58657-0860-01",
"ProductNDC": "58657-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209781",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] ."
},
{
"NDCCode": "58657-860-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) ",
"NDC11Code": "58657-0860-10",
"ProductNDC": "58657-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209781",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"Description": "Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] ."
},
{
"NDCCode": "46708-860-25",
"PackageDescription": "25 kg in 1 DRUM (46708-860-25)",
"NDC11Code": "46708-0860-25",
"ProductNDC": "46708-860",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "72572-860-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (72572-860-25) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "72572-0860-25",
"ProductNDC": "72572-860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212593",
"LabelerName": "Civica, Inc.",
"SubstanceName": "VASOPRESSIN",
"StrengthNumber": "20",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251022",
"SamplePackage": "N",
"IndicationAndUsage": "Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin injection is a sterile, aqueous solution of synthetic arginine vasopressin for administration. The 1 mL and 10 mL solution contains vasopressin 20 units/mL, chlorobutanol 5 mg, sodium chloride 9 mg, water for injection, and glacial acetic acid to adjust pH to 3.5. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L- Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23."
},
{
"NDCCode": "82345-860-25",
"PackageDescription": "1134 g in 1 BOTTLE (82345-860-25) ",
"NDC11Code": "82345-0860-25",
"ProductNDC": "82345-860",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin-lube",
"NonProprietaryName": "Petrolatum, Dimethicone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Hygenic Company, LLC.",
"SubstanceName": "PETROLATUM; DIMETHICONE",
"StrengthNumber": "850; 15",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220401",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects minor cuts scrapes burns – Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "58657-100-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (58657-100-30)",
"NDC11Code": "58657-0100-30",
"ProductNDC": "58657-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prefol-dha",
"NonProprietaryName": "Folic Acid, Ascorbic Acid, Calcium, Iron, Cholecalciferol, .alpha.-tocopherol, D-, Pyridoxine Hydrochloride, Doconexent, Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "30; 28; 160; 400; 300; 55; 1.2; 26; 25",
"StrengthUnit": "[iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "58657-119-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-119-01) ",
"NDC11Code": "58657-0119-01",
"ProductNDC": "58657-119",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260213",
"SamplePackage": "N",
"IndicationAndUsage": "for the preparation of normal isotonic solution of sodium chloride. as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration. any alternative use as directed by a physician."
},
{
"NDCCode": "58657-136-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (58657-136-01)",
"NDC11Code": "58657-0136-01",
"ProductNDC": "58657-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thrivite 19",
"NonProprietaryName": ".beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide And Docusate Sodium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150615",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXIDE",
"StrengthNumber": "30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "58657-160-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (58657-160-12) ",
"NDC11Code": "58657-0160-12",
"ProductNDC": "58657-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Fluoride Chewable",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180817",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180817",
"SamplePackage": "N",
"IndicationAndUsage": "For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F¯) during the period of tooth development results in a significant decrease in the incidence of dental caries. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯."
},
{
"NDCCode": "58657-163-01",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (58657-163-01) ",
"NDC11Code": "58657-0163-01",
"ProductNDC": "58657-163",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multivitamin With Fluoride",
"NonProprietaryName": ".alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180720",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE",
"StrengthNumber": "2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; 300; 4.5; .25",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180720",
"SamplePackage": "N",
"IndicationAndUsage": "Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.25 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements. Children using Multivitamin with Fluoride 0.25 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins."
},
{
"NDCCode": "58657-163-90",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (58657-163-90) ",
"NDC11Code": "58657-0163-90",
"ProductNDC": "58657-163",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multivitamin With Fluoride",
"NonProprietaryName": ".alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180720",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE",
"StrengthNumber": "2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; 300; 4.5; .25",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180720",
"SamplePackage": "N",
"IndicationAndUsage": "Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.25 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements. Children using Multivitamin with Fluoride 0.25 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins."
},
{
"NDCCode": "58657-170-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-170-01) ",
"NDC11Code": "58657-0170-01",
"ProductNDC": "58657-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "M-natal Plus",
"NonProprietaryName": "Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, Niacin, Vitamin B6, Folic Acid, Vitamin B12, Calcium, Iron, Zinc, Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "METHOD PHARMACEUTICALS, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; FERROUS FUMARATE; ZINC; COPPER",
"StrengthNumber": "4000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"Description": "M-Natal Plus Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner."
},
{
"NDCCode": "58657-323-50",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (58657-323-50) / 50 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "58657-0323-50",
"ProductNDC": "58657-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-vite Drops With Fluoride",
"NonProprietaryName": "Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180725",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; VITAMIN D; SODIUM FLUORIDE",
"StrengthNumber": "1500; 35; 400; .25",
"StrengthUnit": "[iU]/mL; mg/mL; [iU]/mL; mg/mL",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180725",
"SamplePackage": "N",
"IndicationAndUsage": "Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.25 mg (See Dosage and Administration). Tri-Vite Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride."
},
{
"NDCCode": "58657-325-50",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (58657-325-50) / 50 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "58657-0325-50",
"ProductNDC": "58657-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multi-vitamin With Fluoride",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Cyanocobalamin, Niacinamide, Pyridoxine Hydrochloride And Sodium Fluoride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170224",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; SODIUM FLUORIDE",
"StrengthNumber": "1500; 35; 400; 5; .5; .6; 2; 8; .4; .25",
"StrengthUnit": "[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170224",
"SamplePackage": "N",
"IndicationAndUsage": "Supplementation of the diet with vitamins A, C and D. Multi-Vitamin Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration). Multi-Vitamin Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride."
},
{
"NDCCode": "58657-327-50",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (58657-327-50) / 50 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "58657-0327-50",
"ProductNDC": "58657-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multi-vitamin Drops With Fluoride And Iron",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Niacinamide, Pyridoxine Hydrochloride, Ferrous Sulfate And Sodium Fluoride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170224",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FERROUS SULFATE; SODIUM FLUORIDE",
"StrengthNumber": "1500; 35; 400; 5; .5; .6; 8; .4; 10; .25",
"StrengthUnit": "[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170224",
"SamplePackage": "N",
"IndicationAndUsage": "Supplementation of the diet with vitamins A, C and D. Multi-Vitamin Drops with Fluoride and Iron 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration). Multi-Vitamin Drops with Fluoride and Iron 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride."
},
{
"NDCCode": "58657-403-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-403-01) ",
"NDC11Code": "58657-0403-01",
"ProductNDC": "58657-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estratest H.s.",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": ".625; 1.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240615",
"SamplePackage": "N",
"IndicationAndUsage": "ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING)."
},
{
"NDCCode": "58657-404-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-404-01) ",
"NDC11Code": "58657-0404-01",
"ProductNDC": "58657-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estratest F.s.",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": "1.25; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240615",
"SamplePackage": "N",
"IndicationAndUsage": "ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING)."
},
{
"NDCCode": "58657-405-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-405-01) ",
"NDC11Code": "58657-0405-01",
"ProductNDC": "58657-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esterified Estrogens And Methyltestosterone",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170815",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": "1.25; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170815",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N"
},
{
"NDCCode": "58657-406-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-406-01) ",
"NDC11Code": "58657-0406-01",
"ProductNDC": "58657-406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esterified Estrogens And Methyltestosterone",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170815",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": ".625; 1.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170815",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N"
},
{
"NDCCode": "58657-407-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-407-01) ",
"NDC11Code": "58657-0407-01",
"ProductNDC": "58657-407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esterified Estrogens And Methyltestosterone",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": ".625; 1.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240615",
"SamplePackage": "N",
"IndicationAndUsage": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING)."
},
{
"NDCCode": "58657-408-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-408-01) ",
"NDC11Code": "58657-0408-01",
"ProductNDC": "58657-408",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esterified Estrogens And Methyltestosterone",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": "1.25; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240615",
"SamplePackage": "N",
"IndicationAndUsage": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING)."
},
{
"NDCCode": "58657-416-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-416-01) ",
"NDC11Code": "58657-0416-01",
"ProductNDC": "58657-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estratest Hs",
"NonProprietaryName": "Esterified Estrogens And Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals",
"SubstanceName": "METHYLTESTOSTERONE; ESTROGENS, ESTERIFIED",
"StrengthNumber": "1.25; .625",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).",
"Description": "ESTRATEST F.S.: Each light green, oval-shaped, biconvex tablet debossed with \"640\" on one side and scripted \"E\" on other side contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. ESTRATEST H.S.: Each dark green, oval-shaped, biconvex tablet debossed with \"639\" on one side and scripted \"E\" on other side contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Methyltestosterone. Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. ESTRATEST F.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide. ESTRATEST H.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide."
},
{
"NDCCode": "58657-417-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-417-01) ",
"NDC11Code": "58657-0417-01",
"ProductNDC": "58657-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estratest Fs",
"NonProprietaryName": "Esterified Estrogens And Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": "1.25; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).",
"Description": "ESTRATEST F.S.: Each light green, oval-shaped, biconvex tablet debossed with \"640\" on one side and scripted \"E\" on other side contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. ESTRATEST H.S.: Each dark green, oval-shaped, biconvex tablet debossed with \"639\" on one side and scripted \"E\" on other side contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Methyltestosterone. Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. ESTRATEST F.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide. ESTRATEST H.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide."
},
{
"NDCCode": "58657-418-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-418-01) ",
"NDC11Code": "58657-0418-01",
"ProductNDC": "58657-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esterified Estrogens And Methyltestosterone Half Strength",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": ".625; 1.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING)."
},
{
"NDCCode": "58657-419-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58657-419-01) ",
"NDC11Code": "58657-0419-01",
"ProductNDC": "58657-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esterified Estrogens And Methyltestosterone Full Strength",
"NonProprietaryName": "Esterified Estrogens, Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE",
"StrengthNumber": "1.25; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING)."
},
{
"NDCCode": "58657-456-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (58657-456-01) ",
"NDC11Code": "58657-0456-01",
"ProductNDC": "58657-456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uro-mp",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE",
"StrengthNumber": "118; 40.8; 36; 10; .12",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141201",
"SamplePackage": "N",
"IndicationAndUsage": "Uro-MP Capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Uro-MP Capsules for oral administration. Each tablet contains: Methenamine 118 mg Sodium Phosphate Monobasic 40.8 mg Phenyl Salicylate 36 mg Methylene Blue 10 mg Hyoscyamine Sulfate 0.12 mg. Inactive ingredients: Lactose, Polyethylene Glycol, Crospovidone, Magnesium Stearate, Colloidal Silicon Dioxide, FD&C Blue # 1, FD&C Red # 3, Titanium Dioxide, Gelatin. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. HYOSCYAMINE SULFATE. [620-61-1] [3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether."
},
{
"NDCCode": "58657-602-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (58657-602-01) ",
"NDC11Code": "58657-0602-01",
"ProductNDC": "58657-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075215",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LABETALOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191122",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin. In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide."
},
{
"NDCCode": "58657-602-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (58657-602-50) ",
"NDC11Code": "58657-0602-50",
"ProductNDC": "58657-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075215",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LABETALOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191122",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin. In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58657-860-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) </PackageDescription>
<NDC11Code>58657-0860-25</NDC11Code>
<ProductNDC>58657-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209781</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] .</Description>
</NDC>
<NDC>
<NDCCode>58657-851-26</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (58657-851-26) / 1 mL in 1 VIAL, SINGLE-DOSE (58657-851-25) </PackageDescription>
<NDC11Code>58657-0851-26</NDC11Code>
<ProductNDC>58657-851</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218412</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
<Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9H 14ClNO 2with a molecular weight of 203.66 g/mol. Its structural formula is depicted below:. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride injection, USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>58657-860-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) </PackageDescription>
<NDC11Code>58657-0860-01</NDC11Code>
<ProductNDC>58657-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209781</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] .</Description>
</NDC>
<NDC>
<NDCCode>58657-860-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) </PackageDescription>
<NDC11Code>58657-0860-10</NDC11Code>
<ProductNDC>58657-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209781</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam, USP per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)] .</Description>
</NDC>
<NDC>
<NDCCode>46708-860-25</NDCCode>
<PackageDescription>25 kg in 1 DRUM (46708-860-25)</PackageDescription>
<NDC11Code>46708-0860-25</NDC11Code>
<ProductNDC>46708-860</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72572-860-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (72572-860-25) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>72572-0860-25</NDC11Code>
<ProductNDC>72572-860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212593</ApplicationNumber>
<LabelerName>Civica, Inc.</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin injection is a sterile, aqueous solution of synthetic arginine vasopressin for administration. The 1 mL and 10 mL solution contains vasopressin 20 units/mL, chlorobutanol 5 mg, sodium chloride 9 mg, water for injection, and glacial acetic acid to adjust pH to 3.5. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L- Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23.</Description>
</NDC>
<NDC>
<NDCCode>82345-860-25</NDCCode>
<PackageDescription>1134 g in 1 BOTTLE (82345-860-25) </PackageDescription>
<NDC11Code>82345-0860-25</NDC11Code>
<ProductNDC>82345-860</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin-lube</ProprietaryName>
<NonProprietaryName>Petrolatum, Dimethicone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>The Hygenic Company, LLC.</LabelerName>
<SubstanceName>PETROLATUM; DIMETHICONE</SubstanceName>
<StrengthNumber>850; 15</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects minor cuts scrapes burns – Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-100-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (58657-100-30)</PackageDescription>
<NDC11Code>58657-0100-30</NDC11Code>
<ProductNDC>58657-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prefol-dha</ProprietaryName>
<NonProprietaryName>Folic Acid, Ascorbic Acid, Calcium, Iron, Cholecalciferol, .alpha.-tocopherol, D-, Pyridoxine Hydrochloride, Doconexent, Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30; 28; 160; 400; 300; 55; 1.2; 26; 25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>58657-119-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-119-01) </PackageDescription>
<NDC11Code>58657-0119-01</NDC11Code>
<ProductNDC>58657-119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the preparation of normal isotonic solution of sodium chloride. as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration. any alternative use as directed by a physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-136-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (58657-136-01)</PackageDescription>
<NDC11Code>58657-0136-01</NDC11Code>
<ProductNDC>58657-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thrivite 19</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide And Docusate Sodium</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>58657-160-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (58657-160-12) </PackageDescription>
<NDC11Code>58657-0160-12</NDC11Code>
<ProductNDC>58657-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Fluoride Chewable</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180817</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F¯) during the period of tooth development results in a significant decrease in the incidence of dental caries. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-163-01</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (58657-163-01) </PackageDescription>
<NDC11Code>58657-0163-01</NDC11Code>
<ProductNDC>58657-163</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; 300; 4.5; .25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.25 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements. Children using Multivitamin with Fluoride 0.25 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-163-90</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (58657-163-90) </PackageDescription>
<NDC11Code>58657-0163-90</NDC11Code>
<ProductNDC>58657-163</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; 300; 4.5; .25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.25 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements. Children using Multivitamin with Fluoride 0.25 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-170-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-170-01) </PackageDescription>
<NDC11Code>58657-0170-01</NDC11Code>
<ProductNDC>58657-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>M-natal Plus</ProprietaryName>
<NonProprietaryName>Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, Niacin, Vitamin B6, Folic Acid, Vitamin B12, Calcium, Iron, Zinc, Copper</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>METHOD PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; FERROUS FUMARATE; ZINC; COPPER</SubstanceName>
<StrengthNumber>4000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>M-Natal Plus Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.</Description>
</NDC>
<NDC>
<NDCCode>58657-323-50</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (58657-323-50) / 50 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>58657-0323-50</NDC11Code>
<ProductNDC>58657-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-vite Drops With Fluoride</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180725</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; VITAMIN D; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1500; 35; 400; .25</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; [iU]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.25 mg (See Dosage and Administration). Tri-Vite Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-325-50</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (58657-325-50) / 50 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>58657-0325-50</NDC11Code>
<ProductNDC>58657-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multi-vitamin With Fluoride</ProprietaryName>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Cyanocobalamin, Niacinamide, Pyridoxine Hydrochloride And Sodium Fluoride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1500; 35; 400; 5; .5; .6; 2; 8; .4; .25</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Supplementation of the diet with vitamins A, C and D. Multi-Vitamin Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration). Multi-Vitamin Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-327-50</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (58657-327-50) / 50 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>58657-0327-50</NDC11Code>
<ProductNDC>58657-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multi-vitamin Drops With Fluoride And Iron</ProprietaryName>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Niacinamide, Pyridoxine Hydrochloride, Ferrous Sulfate And Sodium Fluoride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FERROUS SULFATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1500; 35; 400; 5; .5; .6; 8; .4; 10; .25</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Supplementation of the diet with vitamins A, C and D. Multi-Vitamin Drops with Fluoride and Iron 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration). Multi-Vitamin Drops with Fluoride and Iron 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-403-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-403-01) </PackageDescription>
<NDC11Code>58657-0403-01</NDC11Code>
<ProductNDC>58657-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estratest H.s.</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>.625; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-404-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-404-01) </PackageDescription>
<NDC11Code>58657-0404-01</NDC11Code>
<ProductNDC>58657-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estratest F.s.</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>1.25; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-405-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-405-01) </PackageDescription>
<NDC11Code>58657-0405-01</NDC11Code>
<ProductNDC>58657-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esterified Estrogens And Methyltestosterone</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>1.25; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58657-406-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-406-01) </PackageDescription>
<NDC11Code>58657-0406-01</NDC11Code>
<ProductNDC>58657-406</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esterified Estrogens And Methyltestosterone</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>.625; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58657-407-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-407-01) </PackageDescription>
<NDC11Code>58657-0407-01</NDC11Code>
<ProductNDC>58657-407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esterified Estrogens And Methyltestosterone</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>.625; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-408-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-408-01) </PackageDescription>
<NDC11Code>58657-0408-01</NDC11Code>
<ProductNDC>58657-408</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esterified Estrogens And Methyltestosterone</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>1.25; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotorsymptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-416-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-416-01) </PackageDescription>
<NDC11Code>58657-0416-01</NDC11Code>
<ProductNDC>58657-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estratest Hs</ProprietaryName>
<NonProprietaryName>Esterified Estrogens And Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals</LabelerName>
<SubstanceName>METHYLTESTOSTERONE; ESTROGENS, ESTERIFIED</SubstanceName>
<StrengthNumber>1.25; .625</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
<Description>ESTRATEST F.S.: Each light green, oval-shaped, biconvex tablet debossed with "640" on one side and scripted "E" on other side contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. ESTRATEST H.S.: Each dark green, oval-shaped, biconvex tablet debossed with "639" on one side and scripted "E" on other side contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Methyltestosterone. Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. ESTRATEST F.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide. ESTRATEST H.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>58657-417-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-417-01) </PackageDescription>
<NDC11Code>58657-0417-01</NDC11Code>
<ProductNDC>58657-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estratest Fs</ProprietaryName>
<NonProprietaryName>Esterified Estrogens And Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>1.25; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
<Description>ESTRATEST F.S.: Each light green, oval-shaped, biconvex tablet debossed with "640" on one side and scripted "E" on other side contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. ESTRATEST H.S.: Each dark green, oval-shaped, biconvex tablet debossed with "639" on one side and scripted "E" on other side contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens. Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Methyltestosterone. Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula. ESTRATEST F.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide. ESTRATEST H.S. TABLETS contain the following inactive ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sodium Bicarbonate, Sodium Citrate, Talc, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>58657-418-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-418-01) </PackageDescription>
<NDC11Code>58657-0418-01</NDC11Code>
<ProductNDC>58657-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esterified Estrogens And Methyltestosterone Half Strength</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>.625; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-419-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58657-419-01) </PackageDescription>
<NDC11Code>58657-0419-01</NDC11Code>
<ProductNDC>58657-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esterified Estrogens And Methyltestosterone Full Strength</ProprietaryName>
<NonProprietaryName>Esterified Estrogens, Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>1.25; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.). ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-456-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (58657-456-01) </PackageDescription>
<NDC11Code>58657-0456-01</NDC11Code>
<ProductNDC>58657-456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uro-mp</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>118; 40.8; 36; 10; .12</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uro-MP Capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Uro-MP Capsules for oral administration. Each tablet contains: Methenamine 118 mg Sodium Phosphate Monobasic 40.8 mg Phenyl Salicylate 36 mg Methylene Blue 10 mg Hyoscyamine Sulfate 0.12 mg. Inactive ingredients: Lactose, Polyethylene Glycol, Crospovidone, Magnesium Stearate, Colloidal Silicon Dioxide, FD&C Blue # 1, FD&C Red # 3, Titanium Dioxide, Gelatin. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. HYOSCYAMINE SULFATE. [620-61-1] [3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>58657-602-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (58657-602-01) </PackageDescription>
<NDC11Code>58657-0602-01</NDC11Code>
<ProductNDC>58657-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075215</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LABETALOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin. In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>58657-602-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (58657-602-50) </PackageDescription>
<NDC11Code>58657-0602-50</NDC11Code>
<ProductNDC>58657-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075215</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LABETALOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin. In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide.</Description>
</NDC>
</NDCList>