{
"NDC": [
{
"NDCCode": "54868-1700-6",
"PackageDescription": "40 TABLET in 1 BOTTLE (54868-1700-6)",
"NDC11Code": "54868-1700-06",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-0",
"PackageDescription": "120 TABLET in 1 BOTTLE (54868-1700-0)",
"NDC11Code": "54868-1700-00",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (54868-1700-1)",
"NDC11Code": "54868-1700-01",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-2",
"PackageDescription": "10 TABLET in 1 BOTTLE (54868-1700-2)",
"NDC11Code": "54868-1700-02",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-4",
"PackageDescription": "20 TABLET in 1 BOTTLE (54868-1700-4)",
"NDC11Code": "54868-1700-04",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-5",
"PackageDescription": "150 TABLET in 1 BOTTLE (54868-1700-5)",
"NDC11Code": "54868-1700-05",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-7",
"PackageDescription": "100 TABLET in 1 BOTTLE (54868-1700-7)",
"NDC11Code": "54868-1700-07",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-8",
"PackageDescription": "60 TABLET in 1 BOTTLE (54868-1700-8)",
"NDC11Code": "54868-1700-08",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "54868-1700-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (54868-1700-9)",
"NDC11Code": "54868-1700-09",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "0409-1700-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1700-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1700-01",
"ProductNDC": "0409-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bortezomib",
"NonProprietaryName": "Bortezomib",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208460",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BORTEZOMIB",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220727",
"SamplePackage": "N",
"IndicationAndUsage": "Bortezomib for injection is a proteasome inhibitor indicated for: 1 Treatment of adult patients with multiple myeloma. (1.1), 2 Treatment of adult patients with mantle cell lymphoma. (1.2).",
"Description": "Bortezomib for Injection, a proteasome inhibitor, is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure. The molecular weight is 384.24. The molecular formula is C19H25BN4O4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5. Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its monohydrate form."
},
{
"NDCCode": "0642-0070-01",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0070-01) > 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "00642-0070-01",
"ProductNDC": "0642-0070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "One",
"NonProprietaryName": "Prenatal Supplement With Dha",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Everett Laboratories, Inc.",
"SubstanceName": ".ALPHA.-TOCOPHEROL; ASCORBIC ACID; COPPER; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; MAGNESIUM; NIACIN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC",
"StrengthNumber": "9; 30; 2; .012; 1700; .15; 29; 20; 15; 200; 2.5; 1.8; 1.6; 330; 25; 25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fatty Acids, Omega-3 [CS], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Omega-3 Fatty Acid [EPC], 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": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110613",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol-One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol-One does not contain fish, fish oils, fish proteins or fish byproducts.",
"Description": "Other Ingredients. Gelatin (Bovine BSE-free), Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Dicalcium Phosphate, Soy Lecithin, Vegetable Oil, FD&C Blue #1, Titanium Dioxide (color), Sodium Thiosulfate, Caramel (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate. Contains: Soy."
},
{
"NDCCode": "0642-0070-03",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0070-03) / 3 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "00642-0070-03",
"ProductNDC": "0642-0070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "One",
"NonProprietaryName": "Prenatal Supplement With Dha",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; .ALPHA.-TOCOPHEROL; IRON",
"StrengthNumber": "330; 30; 1.6; 1.8; 15; 2.5; .012; 1700; .15; 20; 25; 2; 25; 200; 9; 29",
"StrengthUnit": "ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fatty Acids, Omega-3 [CS], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Omega-3 Fatty Acid [EPC], 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": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "Y",
"IndicationAndUsage": "Vitafol ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.*.",
"Description": "Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide. Contains: Soy."
},
{
"NDCCode": "0642-0070-30",
"PackageDescription": "5 BLISTER PACK in 1 BOX (0642-0070-30) / 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "00642-0070-30",
"ProductNDC": "0642-0070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "One",
"NonProprietaryName": "Prenatal Supplement With Dha",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; .ALPHA.-TOCOPHEROL; IRON",
"StrengthNumber": "330; 30; 1.6; 1.8; 15; 2.5; .012; 1700; .15; 20; 25; 2; 25; 200; 9; 29",
"StrengthUnit": "ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fatty Acids, Omega-3 [CS], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Omega-3 Fatty Acid [EPC], 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": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110613",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.*.",
"Description": "Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide. Contains: Soy."
},
{
"NDCCode": "0642-0207-03",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0207-03) / 3 TABLET in 1 BLISTER PACK",
"NDC11Code": "00642-0207-03",
"ProductNDC": "0642-0207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strovite One",
"ProprietaryNameSuffix": "Caplets",
"NonProprietaryName": "Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "MANGANESE; VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SULFATE; CHROMIUM; ALPHA LIPOIC ACID; LUTEIN",
"StrengthNumber": "1.5; 900; 7.5; 300; 25; 45; 20; 5; 25; 25; 1700; 100; 50; 100; 50; 25; 1.5; 50; 15; 5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010504",
"SamplePackage": "N",
"IndicationAndUsage": "STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.",
"Description": "Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol."
},
{
"NDCCode": "0642-0207-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (0642-0207-90) ",
"NDC11Code": "00642-0207-90",
"ProductNDC": "0642-0207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strovite One",
"ProprietaryNameSuffix": "Caplets",
"NonProprietaryName": "Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "MANGANESE; VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SULFATE; CHROMIUM; ALPHA LIPOIC ACID; LUTEIN",
"StrengthNumber": "1.5; 900; 7.5; 300; 25; 45; 20; 5; 25; 25; 1700; 100; 50; 100; 50; 25; 1.5; 50; 15; 5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010504",
"SamplePackage": "N",
"IndicationAndUsage": "STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.",
"Description": "Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol."
},
{
"NDCCode": "49672-100-01",
"PackageDescription": "125 mL in 1 PACKAGE (49672-100-01)",
"NDC11Code": "49672-0100-01",
"ProductNDC": "49672-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Techniblock Ultra Sunscreen",
"NonProprietaryName": "Avobenzone,octinoxate,oxybenzone,padimate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100405",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "The Myles Group LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OXYBENZONE; PADIMATE A",
"StrengthNumber": ".6; 6.3; 3.4; 5.1",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses. Helps prevent Sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.",
"Description": "See base of tin for batch detailsThis product has a security tab on either side of thedust cover. Do not use if these tabs are broken,missing or have been tampered with. Manufactured by:Technikon Laboratories (Ply) Ltd P .0 . Box 1 5 0, Maraisburg, 1700, RSA. Distributed By:The Myles Group LLC 4433 MountainRd , Ste#3 Pasadena, MD 21122Tel: (443) 305-2304, PRODUCT OF SOUTH AFRICA."
},
{
"NDCCode": "53645-1700-2",
"PackageDescription": "23 g in 1 BOTTLE (53645-1700-2) ",
"NDC11Code": "53645-1700-02",
"ProductNDC": "53645-1700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Fluorica",
"NonProprietaryName": "Calcarea Fluorica",
"DosageFormName": "GLOBULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131007",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Botanica, LLC",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/23g",
"Status": "Active",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131007",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of cysts, ganglions, swollen lymph nodes. May also be used for standard homeopathic indications or as directed by your physician."
},
{
"NDCCode": "59088-022-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-022-54) ",
"NDC11Code": "59088-0022-54",
"ProductNDC": "59088-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Boostervite",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; PANTOTHENIC ACID; ORANGE JUICE; BIOTIN; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; THIAMINE MONONITRATE; PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; BROCCOLI SPROUT; PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT; KALE; WITHANIA SOMNIFERA ROOT",
"StrengthNumber": "18; 50; 2.5; 300; 10; 10; 100; 1000; 100; 10; 10; 10; 2.5; 2.5; 2.5; 60",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260619",
"SamplePackage": "N",
"IndicationAndUsage": "Boostervite contains a combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of a healthcare provider.",
"Description": "Each Tablet Contains. Vitamin C (as ascorbic acid)……………….……………… 100 mg Vitamin D3 (as cholecalciferol)…………….……. 10 mcg (400 IU) Thiamin (as thiamine mononitrate)…………...……………. 10 mg Riboflavin ...................…………………………...………….. 10 mg Niacin (as niacinamide)…………………………....…………10 mg Vitamin B6 (as pyridoxine hydrochloride)………….……….10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)………………….….... 100 mcg Biotin (as d-Biotin)……………………...…….................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)………....… 50 mg Iron (as Ferrous Fumarate)……………………………......... 18 mg Withania somnifera (Ashwagandha) Root Powder….....…. 60 mg Brassica oleracea acephala (Kale) Powder……….…...…. 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder..…...... 2.5 mg Citrus sinensis (Orange) Juice Powder……....................... 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum)."
},
{
"NDCCode": "59088-078-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-078-54) ",
"NDC11Code": "59088-0078-54",
"ProductNDC": "59088-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatol",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260821",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; .ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; CHOLINE BITARTRATE; FERROUS FUMARATE; POTASSIUM IODIDE",
"StrengthNumber": "3.4; 20; 120; 1000; 10; 200; 1500; 3; 25; 2.6; 30; 200; 45; 50; 50; 70; 20; 55; 27; 150",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260821",
"SamplePackage": "N",
"IndicationAndUsage": "PNV Prenatol TM is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PNV Prenatol TM may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Each tablet contains. Vitamin A (as retinyl acetate)…………...1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)……………….………………. 120 mg Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (as Vitamin E)……….....……. 30 mg Thiamin (as thiamine mononitrate)…………...……………….3 mg Riboflavin.....................…………………………...…...……. 3.4 mg Niacin (as niacinamide)…………………………....………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)………….………..50 mg Folate (as l-5-methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as cyanocobalamin)………………….……….10 mcg. Choline (as choline bitartrate)..............................................55 mg Calcium (as calcium carbonate)……………………...……. 200 mg. Iron (as ferrous fumarate)...................................................27 mg. Iodine (as potassium iodide)............................................150 mcg Magnesium (as magnesium oxide)……………………...….200 mg Zinc (as zinc oxide)………………………………………....... 25 mg Selenium (as selenium amino acid chelate)……………….70 mcg Manganese (as manganese sulfate)………………………. 2.6 mg Chromium (as chromium polynicotinate)………………..... 45 mcg Molybdenum (as molybdenum amino acid chelate)……... 50 mcg. Other Ingredients:Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400)."
},
{
"NDCCode": "59088-139-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-139-54) ",
"NDC11Code": "59088-0139-54",
"ProductNDC": "59088-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitalux",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE",
"StrengthNumber": "200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Vitalux caplets are a prescription multivitamin formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed. Vitalux caplets may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "DESCRIPTION:ACTIVE INGREDIENTS. Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)…………………………….........… 120 mg Vitamin D3 (as cholecalciferol)………………….......... 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (Vitamin E)……………...... 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………...........… 3 mg Riboflavin ..............................……………………………………. 3.4 mg Niacin (as niacinamide)………………………………...........…… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………........………. 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt )…. 1700 mcg DFE (1000 mcg L-Methylfolate) Vitamin B12 (as cyanocobalamin)………………........………… 10 mcg Choline (as choline bitartrate)………………………...........…….. 55 mg Calcium (as calcium carbonate)……………………..........……. 200 mg Iron (as ferrous fumarate)………………………………............… 27 mg Iodine (as potassium iodine)…………………………...........… 150 mcg Magnesium (as magnesium oxide)…………………..........…… 200 mg Zinc (as zinc oxide)…………………………………............…….. 25 mg Selenium (as selenium amino acid chelate)………......………. 70 mcg Manganese (as manganese sulfate)………………........……… 2.6 mg Chromium (as chromium polynicotinate)…………..........…….. 45 mcg Molybdenum (as molybdenum amino acid chelate)…......…… 50 mcg. OTHER INGREDIENTS: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400)."
},
{
"NDCCode": "59088-156-54",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (59088-156-54) ",
"NDC11Code": "59088-0156-54",
"ProductNDC": "59088-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Menatrol",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231218",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; RHUBARB; CALCIUM CARBONATE",
"StrengthNumber": "1.5; 600; 1000; 100; 4; 220",
"StrengthUnit": "mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.",
"Description": "Full Prescribing Information:Drug Description:Menatrol Capsules are a comprehensive dietary supplement tailored for individuals undergoing menopause. This specialized formulation offers a blend of vitamins, minerals, and plant extracts aiming to alleviate common menopausal symptoms:. Vitamin D3 (Cholecalciferol): Contained in a dose of 15 mcg (600 IU), Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Vitamin B6 (Pyridoxine Hydrochloride): At a dosage of 1.5 mg, Vitamin B6 is integral for mood stabilization and promoting energy. Typically, adults are advised to consume 1.3-2.0 mg per day. Always refer to the supplement label for specific dosages. Folate (L-5-Methyltetrahydrofolate calcium salt): Provided in a measure of 1700 mcg DFE (with 1000 mcg as L-5-Methylfolate), folate is pivotal for holistic health, potentially aiding in mood enhancement and energy regulation. An average adult dosage is between 400-800 mcg daily. Calcium (Calcium Carbonate): At a concentration of 220 mg, calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Oxide): Present in an amount of 100 mg, magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. On average, adults are recommended to consume 300-400 mg per day, though individual requirements can differ. Rhapontic Rhubarb: Rhapontic rhubarb (Rheum rhaponticum) is a natural ingredient that some women use to address menopausal symptoms, including hot flashes and mood swings. The appropriate dosage for this specific ingredient may vary, so consult the product label or a licensed healthcare practitioner for guidance. Each capsule contains: Vitamin D3 (as Cholecalciferol)....................................15 mcg (600 IU) Vitamin B6 (as Pyridoxine Hydrochloride)....................1.5 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg as L-5-Methylfolate) Calcium (as Calcium Carbonate)..................................220 mg Magnesium (as Magnesium Oxide)..............................100 mg Rhapontic Rhubarb (Siberian Rhubarb) Root Extract...4 mg."
},
{
"NDCCode": "59088-164-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-164-54) ",
"NDC11Code": "59088-0164-54",
"ProductNDC": "59088-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexyl",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200829",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
"StrengthNumber": "30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200829",
"SamplePackage": "N",
"IndicationAndUsage": "Vitrexyl is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)……………. 30 mg (30IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-165-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-165-54) ",
"NDC11Code": "59088-0165-54",
"ProductNDC": "59088-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexyl Plus Iron",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200824",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM",
"StrengthNumber": "35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55",
"StrengthUnit": "ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200824",
"SamplePackage": "N",
"IndicationAndUsage": "Vitrexyl + Iron is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, alongwith a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well ascases of metabolic stress, and in convalescence.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: BHT, dicalcium phosphate, organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-166-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-166-54) ",
"NDC11Code": "59088-0166-54",
"ProductNDC": "59088-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatrix",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200829",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; CHROMIUM NICOTINATE; SELENIUM; POTASSIUM IODIDE; MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE",
"StrengthNumber": "27; 25; 50; 55; 45; 70; 150; 200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200829",
"SamplePackage": "N",
"IndicationAndUsage": "Prenatrix is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatrix may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Active ingredients: Each caplet contains:. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as Choline Bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: BHT, dicalcium phosphate, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-167-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-167-54) ",
"NDC11Code": "59088-0167-54",
"ProductNDC": "59088-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexate",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
"StrengthNumber": "30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-168-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-168-54) ",
"NDC11Code": "59088-0168-54",
"ProductNDC": "59088-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrexate Fe",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM",
"StrengthNumber": "35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55",
"StrengthUnit": "ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "Vitrexate FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for the treatment of a condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-169-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-169-54) ",
"NDC11Code": "59088-0169-54",
"ProductNDC": "59088-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatryl",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE",
"StrengthNumber": "200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201130",
"SamplePackage": "N",
"IndicationAndUsage": "Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-171-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-171-54) ",
"NDC11Code": "59088-0171-54",
"ProductNDC": "59088-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitranol",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; SELENIUM; FOLIC ACID; MAGNESIUM OXIDE; MOLYBDENUM; THIAMINE MONONITRATE; CYANOCOBALAMIN; VITAMIN A ACETATE; CHROMIUM NICOTINATE; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; ZINC OXIDE; CALCIUM CARBONATE; ASCORBIC ACID; MANGANESE SULFATE",
"StrengthNumber": "20; 55; 1000; 200; 45; 3; 8; 1500; 35; 20; 3.4; 20; 30; 25; 200; 120; 2.3",
"StrengthUnit": "mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-172-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-172-54) ",
"NDC11Code": "59088-0172-54",
"ProductNDC": "59088-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prometa",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE",
"StrengthNumber": "200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-173-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-173-54) ",
"NDC11Code": "59088-0173-54",
"ProductNDC": "59088-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitranol Fe",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM",
"StrengthNumber": "35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55",
"StrengthUnit": "ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N",
"IndicationAndUsage": "Vitranol FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)…………………………. 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>54868-1700-6</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (54868-1700-6)</PackageDescription>
<NDC11Code>54868-1700-06</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-0</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (54868-1700-0)</PackageDescription>
<NDC11Code>54868-1700-00</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54868-1700-1)</PackageDescription>
<NDC11Code>54868-1700-01</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-2</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (54868-1700-2)</PackageDescription>
<NDC11Code>54868-1700-02</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-4</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (54868-1700-4)</PackageDescription>
<NDC11Code>54868-1700-04</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-5</NDCCode>
<PackageDescription>150 TABLET in 1 BOTTLE (54868-1700-5)</PackageDescription>
<NDC11Code>54868-1700-05</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-7</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (54868-1700-7)</PackageDescription>
<NDC11Code>54868-1700-07</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-8</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (54868-1700-8)</PackageDescription>
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<ProductNDC>54868-1700</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>54868-1700-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (54868-1700-9)</PackageDescription>
<NDC11Code>54868-1700-09</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>0409-1700-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1700-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-1700-01</NDC11Code>
<ProductNDC>0409-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bortezomib</ProprietaryName>
<NonProprietaryName>Bortezomib</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208460</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BORTEZOMIB</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bortezomib for injection is a proteasome inhibitor indicated for: 1 Treatment of adult patients with multiple myeloma. (1.1), 2 Treatment of adult patients with mantle cell lymphoma. (1.2).</IndicationAndUsage>
<Description>Bortezomib for Injection, a proteasome inhibitor, is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure. The molecular weight is 384.24. The molecular formula is C19H25BN4O4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5. Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its monohydrate form.</Description>
</NDC>
<NDC>
<NDCCode>0642-0070-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0070-01) > 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0070-01</NDC11Code>
<ProductNDC>0642-0070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>One</ProprietaryNameSuffix>
<NonProprietaryName>Prenatal Supplement With Dha</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Everett Laboratories, Inc.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL; ASCORBIC ACID; COPPER; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; MAGNESIUM; NIACIN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC</SubstanceName>
<StrengthNumber>9; 30; 2; .012; 1700; .15; 29; 20; 15; 200; 2.5; 1.8; 1.6; 330; 25; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/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], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fatty Acids, Omega-3 [CS], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Omega-3 Fatty Acid [EPC], 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>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol-One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol-One does not contain fish, fish oils, fish proteins or fish byproducts.</IndicationAndUsage>
<Description>Other Ingredients. Gelatin (Bovine BSE-free), Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Dicalcium Phosphate, Soy Lecithin, Vegetable Oil, FD&C Blue #1, Titanium Dioxide (color), Sodium Thiosulfate, Caramel (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate. Contains: Soy.</Description>
</NDC>
<NDC>
<NDCCode>0642-0070-03</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0070-03) / 3 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0070-03</NDC11Code>
<ProductNDC>0642-0070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>One</ProprietaryNameSuffix>
<NonProprietaryName>Prenatal Supplement With Dha</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; .ALPHA.-TOCOPHEROL; IRON</SubstanceName>
<StrengthNumber>330; 30; 1.6; 1.8; 15; 2.5; .012; 1700; .15; 20; 25; 2; 25; 200; 9; 29</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fatty Acids, Omega-3 [CS], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Omega-3 Fatty Acid [EPC], 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>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Vitafol ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.*.</IndicationAndUsage>
<Description>Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide. Contains: Soy.</Description>
</NDC>
<NDC>
<NDCCode>0642-0070-30</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 BOX (0642-0070-30) / 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0070-30</NDC11Code>
<ProductNDC>0642-0070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>One</ProprietaryNameSuffix>
<NonProprietaryName>Prenatal Supplement With Dha</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; .ALPHA.-TOCOPHEROL; IRON</SubstanceName>
<StrengthNumber>330; 30; 1.6; 1.8; 15; 2.5; .012; 1700; .15; 20; 25; 2; 25; 200; 9; 29</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fatty Acids, Omega-3 [CS], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Omega-3 Fatty Acid [EPC], 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>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.*.</IndicationAndUsage>
<Description>Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide. Contains: Soy.</Description>
</NDC>
<NDC>
<NDCCode>0642-0207-03</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0207-03) / 3 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0207-03</NDC11Code>
<ProductNDC>0642-0207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strovite One</ProprietaryName>
<ProprietaryNameSuffix>Caplets</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>MANGANESE; VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SULFATE; CHROMIUM; ALPHA LIPOIC ACID; LUTEIN</SubstanceName>
<StrengthNumber>1.5; 900; 7.5; 300; 25; 45; 20; 5; 25; 25; 1700; 100; 50; 100; 50; 25; 1.5; 50; 15; 5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.</IndicationAndUsage>
<Description>Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol.</Description>
</NDC>
<NDC>
<NDCCode>0642-0207-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0642-0207-90) </PackageDescription>
<NDC11Code>00642-0207-90</NDC11Code>
<ProductNDC>0642-0207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strovite One</ProprietaryName>
<ProprietaryNameSuffix>Caplets</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>MANGANESE; VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SULFATE; CHROMIUM; ALPHA LIPOIC ACID; LUTEIN</SubstanceName>
<StrengthNumber>1.5; 900; 7.5; 300; 25; 45; 20; 5; 25; 25; 1700; 100; 50; 100; 50; 25; 1.5; 50; 15; 5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.</IndicationAndUsage>
<Description>Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol.</Description>
</NDC>
<NDC>
<NDCCode>49672-100-01</NDCCode>
<PackageDescription>125 mL in 1 PACKAGE (49672-100-01)</PackageDescription>
<NDC11Code>49672-0100-01</NDC11Code>
<ProductNDC>49672-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Techniblock Ultra Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone,octinoxate,oxybenzone,padimate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>The Myles Group LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE; PADIMATE A</SubstanceName>
<StrengthNumber>.6; 6.3; 3.4; 5.1</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. Helps prevent Sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.</IndicationAndUsage>
<Description>See base of tin for batch detailsThis product has a security tab on either side of thedust cover. Do not use if these tabs are broken,missing or have been tampered with. Manufactured by:Technikon Laboratories (Ply) Ltd P .0 . Box 1 5 0, Maraisburg, 1700, RSA. Distributed By:The Myles Group LLC 4433 MountainRd , Ste#3 Pasadena, MD 21122Tel: (443) 305-2304, PRODUCT OF SOUTH AFRICA.</Description>
</NDC>
<NDC>
<NDCCode>53645-1700-2</NDCCode>
<PackageDescription>23 g in 1 BOTTLE (53645-1700-2) </PackageDescription>
<NDC11Code>53645-1700-02</NDC11Code>
<ProductNDC>53645-1700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Fluorica</ProprietaryName>
<NonProprietaryName>Calcarea Fluorica</NonProprietaryName>
<DosageFormName>GLOBULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131007</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Botanica, LLC</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/23g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of cysts, ganglions, swollen lymph nodes. May also be used for standard homeopathic indications or as directed by your physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-022-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-022-54) </PackageDescription>
<NDC11Code>59088-0022-54</NDC11Code>
<ProductNDC>59088-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Boostervite</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; PANTOTHENIC ACID; ORANGE JUICE; BIOTIN; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; THIAMINE MONONITRATE; PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; BROCCOLI SPROUT; PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT; KALE; WITHANIA SOMNIFERA ROOT</SubstanceName>
<StrengthNumber>18; 50; 2.5; 300; 10; 10; 100; 1000; 100; 10; 10; 10; 2.5; 2.5; 2.5; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Boostervite contains a combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of a healthcare provider.</IndicationAndUsage>
<Description>Each Tablet Contains. Vitamin C (as ascorbic acid)……………….……………… 100 mg Vitamin D3 (as cholecalciferol)…………….……. 10 mcg (400 IU) Thiamin (as thiamine mononitrate)…………...……………. 10 mg Riboflavin ...................…………………………...………….. 10 mg Niacin (as niacinamide)…………………………....…………10 mg Vitamin B6 (as pyridoxine hydrochloride)………….……….10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)………………….….... 100 mcg Biotin (as d-Biotin)……………………...…….................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)………....… 50 mg Iron (as Ferrous Fumarate)……………………………......... 18 mg Withania somnifera (Ashwagandha) Root Powder….....…. 60 mg Brassica oleracea acephala (Kale) Powder……….…...…. 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder..…...... 2.5 mg Citrus sinensis (Orange) Juice Powder……....................... 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum).</Description>
</NDC>
<NDC>
<NDCCode>59088-078-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-078-54) </PackageDescription>
<NDC11Code>59088-0078-54</NDC11Code>
<ProductNDC>59088-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatol</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260821</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; .ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; CHOLINE BITARTRATE; FERROUS FUMARATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>3.4; 20; 120; 1000; 10; 200; 1500; 3; 25; 2.6; 30; 200; 45; 50; 50; 70; 20; 55; 27; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PNV Prenatol TM is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PNV Prenatol TM may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Each tablet contains. Vitamin A (as retinyl acetate)…………...1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)……………….………………. 120 mg Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (as Vitamin E)……….....……. 30 mg Thiamin (as thiamine mononitrate)…………...……………….3 mg Riboflavin.....................…………………………...…...……. 3.4 mg Niacin (as niacinamide)…………………………....………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)………….………..50 mg Folate (as l-5-methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as cyanocobalamin)………………….……….10 mcg. Choline (as choline bitartrate)..............................................55 mg Calcium (as calcium carbonate)……………………...……. 200 mg. Iron (as ferrous fumarate)...................................................27 mg. Iodine (as potassium iodide)............................................150 mcg Magnesium (as magnesium oxide)……………………...….200 mg Zinc (as zinc oxide)………………………………………....... 25 mg Selenium (as selenium amino acid chelate)……………….70 mcg Manganese (as manganese sulfate)………………………. 2.6 mg Chromium (as chromium polynicotinate)………………..... 45 mcg Molybdenum (as molybdenum amino acid chelate)……... 50 mcg. Other Ingredients:Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400).</Description>
</NDC>
<NDC>
<NDCCode>59088-139-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-139-54) </PackageDescription>
<NDC11Code>59088-0139-54</NDC11Code>
<ProductNDC>59088-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitalux</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitalux caplets are a prescription multivitamin formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed. Vitalux caplets may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>DESCRIPTION:ACTIVE INGREDIENTS. Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)…………………………….........… 120 mg Vitamin D3 (as cholecalciferol)………………….......... 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (Vitamin E)……………...... 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………...........… 3 mg Riboflavin ..............................……………………………………. 3.4 mg Niacin (as niacinamide)………………………………...........…… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………........………. 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt )…. 1700 mcg DFE (1000 mcg L-Methylfolate) Vitamin B12 (as cyanocobalamin)………………........………… 10 mcg Choline (as choline bitartrate)………………………...........…….. 55 mg Calcium (as calcium carbonate)……………………..........……. 200 mg Iron (as ferrous fumarate)………………………………............… 27 mg Iodine (as potassium iodine)…………………………...........… 150 mcg Magnesium (as magnesium oxide)…………………..........…… 200 mg Zinc (as zinc oxide)…………………………………............…….. 25 mg Selenium (as selenium amino acid chelate)………......………. 70 mcg Manganese (as manganese sulfate)………………........……… 2.6 mg Chromium (as chromium polynicotinate)…………..........…….. 45 mcg Molybdenum (as molybdenum amino acid chelate)…......…… 50 mcg. OTHER INGREDIENTS: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400).</Description>
</NDC>
<NDC>
<NDCCode>59088-156-54</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (59088-156-54) </PackageDescription>
<NDC11Code>59088-0156-54</NDC11Code>
<ProductNDC>59088-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Menatrol</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; RHUBARB; CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1.5; 600; 1000; 100; 4; 220</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.</IndicationAndUsage>
<Description>Full Prescribing Information:Drug Description:Menatrol Capsules are a comprehensive dietary supplement tailored for individuals undergoing menopause. This specialized formulation offers a blend of vitamins, minerals, and plant extracts aiming to alleviate common menopausal symptoms:. Vitamin D3 (Cholecalciferol): Contained in a dose of 15 mcg (600 IU), Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Vitamin B6 (Pyridoxine Hydrochloride): At a dosage of 1.5 mg, Vitamin B6 is integral for mood stabilization and promoting energy. Typically, adults are advised to consume 1.3-2.0 mg per day. Always refer to the supplement label for specific dosages. Folate (L-5-Methyltetrahydrofolate calcium salt): Provided in a measure of 1700 mcg DFE (with 1000 mcg as L-5-Methylfolate), folate is pivotal for holistic health, potentially aiding in mood enhancement and energy regulation. An average adult dosage is between 400-800 mcg daily. Calcium (Calcium Carbonate): At a concentration of 220 mg, calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Oxide): Present in an amount of 100 mg, magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. On average, adults are recommended to consume 300-400 mg per day, though individual requirements can differ. Rhapontic Rhubarb: Rhapontic rhubarb (Rheum rhaponticum) is a natural ingredient that some women use to address menopausal symptoms, including hot flashes and mood swings. The appropriate dosage for this specific ingredient may vary, so consult the product label or a licensed healthcare practitioner for guidance. Each capsule contains: Vitamin D3 (as Cholecalciferol)....................................15 mcg (600 IU) Vitamin B6 (as Pyridoxine Hydrochloride)....................1.5 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg as L-5-Methylfolate) Calcium (as Calcium Carbonate)..................................220 mg Magnesium (as Magnesium Oxide)..............................100 mg Rhapontic Rhubarb (Siberian Rhubarb) Root Extract...4 mg.</Description>
</NDC>
<NDC>
<NDCCode>59088-164-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-164-54) </PackageDescription>
<NDC11Code>59088-0164-54</NDC11Code>
<ProductNDC>59088-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexyl</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200829</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitrexyl is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)……………. 30 mg (30IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-165-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-165-54) </PackageDescription>
<NDC11Code>59088-0165-54</NDC11Code>
<ProductNDC>59088-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexyl Plus Iron</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200824</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM</SubstanceName>
<StrengthNumber>35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitrexyl + Iron is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, alongwith a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well ascases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: BHT, dicalcium phosphate, organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-166-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-166-54) </PackageDescription>
<NDC11Code>59088-0166-54</NDC11Code>
<ProductNDC>59088-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatrix</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200829</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; CHROMIUM NICOTINATE; SELENIUM; POTASSIUM IODIDE; MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>27; 25; 50; 55; 45; 70; 150; 200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/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], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenatrix is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatrix may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Active ingredients: Each caplet contains:. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as Choline Bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: BHT, dicalcium phosphate, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-167-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-167-54) </PackageDescription>
<NDC11Code>59088-0167-54</NDC11Code>
<ProductNDC>59088-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexate</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>30; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 1000; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-168-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-168-54) </PackageDescription>
<NDC11Code>59088-0168-54</NDC11Code>
<ProductNDC>59088-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrexate Fe</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM</SubstanceName>
<StrengthNumber>35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitrexate FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for the treatment of a condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selinium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-169-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-169-54) </PackageDescription>
<NDC11Code>59088-0169-54</NDC11Code>
<ProductNDC>59088-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatryl</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-171-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-171-54) </PackageDescription>
<NDC11Code>59088-0171-54</NDC11Code>
<ProductNDC>59088-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitranol</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; SELENIUM; FOLIC ACID; MAGNESIUM OXIDE; MOLYBDENUM; THIAMINE MONONITRATE; CYANOCOBALAMIN; VITAMIN A ACETATE; CHROMIUM NICOTINATE; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; ZINC OXIDE; CALCIUM CARBONATE; ASCORBIC ACID; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>20; 55; 1000; 200; 45; 3; 8; 1500; 35; 20; 3.4; 20; 30; 25; 200; 120; 2.3</StrengthNumber>
<StrengthUnit>mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-172-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-172-54) </PackageDescription>
<NDC11Code>59088-0172-54</NDC11Code>
<ProductNDC>59088-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prometa</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MAGNESIUM OXIDE; MANGANESE SULFATE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; MOLYBDENUM; CHOLINE BITARTRATE; SELENIUM; CHROMIUM NICOTINATE; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>200; 2.6; 1500; 120; 20; 30; 3; 3.4; 20; 50; 1000; 10; 200; 27; 25; 50; 55; 70; 45; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. May be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Full Prescribing Information. Active ingredient: Each caplet contains:. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………… 10 mcg Choline (as choline bitartrate)…………………………….. 55 mg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Iodine (as potassium iodine)…………………………….150 mcg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 70 mcg Manganese (as manganese sulfate)……………………… 2.6 mg Chromium (as chromium polynicotinate)……………….. 45 mcg Molybdenum (as molybdenum amino acid chelate)……… 50 mcg. Other Ingredients: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-173-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-173-54) </PackageDescription>
<NDC11Code>59088-0173-54</NDC11Code>
<ProductNDC>59088-173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitranol Fe</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHROMIUM NICOTINATE; FOLIC ACID; VITAMIN A ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; ASCORBIC ACID; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; FERROUS FUMARATE; MAGNESIUM OXIDE; MOLYBDENUM; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; SELENIUM</SubstanceName>
<StrengthNumber>35; 1000; 1500; 3.4; 20; 20; 8; 200; 120; 3; 25; 2.3; 27; 200; 45; 30; 20; 55</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitranol FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU) Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU) Thiamin (as thiamine mononitrate)…………………………. 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg Calcium (as calcium carbonate)…………………………. 200 mg Iron (as ferrous fumarate)………………………………… 27 mg Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium amino acid chelate)………………. 55 mcg Manganese (as manganese sulfate)……………………… 2.3 mg Chromium (as chromium polynicotinate)……………….. 35 mcg Molybdenum (as molybdenum amino acid chelate)……… 45 mcg. Other Ingredients: Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).</Description>
</NDC>
</NDCList>