{
"NDC": [
{
"NDCCode": "0642-7463-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00642-7463-12",
"ProductNDC": "0642-7463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benznidazole",
"NonProprietaryName": "Benznidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180330",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209570",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "BENZNIDAZOLE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180330",
"SamplePackage": "N",
"IndicationAndUsage": "Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ( 14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.",
"Description": "Benznidazole Tablets contain benznidazole, a nitroimidazole antimicrobial. The chemical name of benznidazole is N-benzyl-2-(2-nitro-1H-imidazol-1-yl) acetamide. The empirical formula is C 12H 12N 4O 3 and the molecular weight is 260.246 g/mol. The structural formula is:. Figure 1: Benznidazole Structure. Benznidazole is a yellowish, practically crystalline powder that is practically insoluble in water, sparingly soluble in acetone and ethanol, and slightly soluble in methanol. Benznidazole Tablets are white round tablets each containing 12.5 mg or 100 mg of benznidazole, for oral use. The 100 mg white tablets are round and functionally scored twice as a cross on both sides debossed with “E” on one side of each quarter portion. The 12.5 mg white tablets are round and unscored debossed with “E” on one side. The inactive ingredients are as follows: magnesium stearate, NF; microcrystalline cellulose, NF; monohydrate lactose, NF; pre-gelatinized corn starch, NF; and sodium croscarmellose, NF."
},
{
"NDCCode": "0642-0072-12",
"PackageDescription": "100 CAPSULE in 1 BOX (0642-0072-12) ",
"NDC11Code": "00642-0072-12",
"ProductNDC": "0642-0072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Caplet",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, And Iron",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19850501",
"EndMarketingDate": "20230113",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": ".ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D",
"StrengthNumber": "10; 60; 125; 5; 1; 27; 15; 15; 1.8; 1.1; 6000; 400",
"StrengthUnit": "[iU]/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19850501",
"EndMarketingDatePackage": "20230113",
"SamplePackage": "N"
},
{
"NDCCode": "0642-0079-12",
"PackageDescription": "100 TABLET in 1 CARTON (0642-0079-12) ",
"NDC11Code": "00642-0079-12",
"ProductNDC": "0642-0079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol Ob",
"ProprietaryNameSuffix": "Caplet",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, And Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": ".ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC",
"StrengthNumber": "30; 70; 100; 2; 12; 1; 65; 25; 18; 2.5; 1.8; 1.6; 2700; 400; 25",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20021202",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol ®-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*.",
"Description": "Each Caplet contains. Other Ingredients: microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, hydroxypropyl methylcellulose, dicalcium phosphate, acacia gum, titanium dioxide, polydextrose, starch, magnesium stearate, triacetin, modified food starch, mannitol, vitamin E alcohol, polyethylene glycol, talc, FD&C Blue #1, FD&C Blue #2."
},
{
"NDCCode": "11523-0642-1",
"PackageDescription": "1 CELLO PACK in 1 CARTON (11523-0642-1) > 12 DISC in 1 CELLO PACK",
"NDC11Code": "11523-0642-01",
"ProductNDC": "11523-0642",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr. Scholls",
"ProprietaryNameSuffix": "Clear Away Wrt Removers With Duragel Technology",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "DISC",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160201",
"EndMarketingDate": "20220131",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358B",
"LabelerName": "Bayer Health Care LLC.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".4",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2022-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160201",
"EndMarketingDatePackage": "20220131",
"SamplePackage": "N"
},
{
"NDCCode": "21130-642-12",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (21130-642-12) ",
"NDC11Code": "21130-0642-12",
"ProductNDC": "21130-642",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190331",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Safeway, Inc.",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190331",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching."
},
{
"NDCCode": "49035-642-12",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (49035-642-12) ",
"NDC11Code": "49035-0642-12",
"ProductNDC": "49035-642",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190331",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190331",
"EndMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching."
},
{
"NDCCode": "64850-642-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (64850-642-12) ",
"NDC11Code": "64850-0642-12",
"ProductNDC": "64850-642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212418",
"LabelerName": "Elite Laboratories, Inc.",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including acetaminophen and codeine phosphate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Codeine phosphate, USP, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C18H21NO3H3PO4½H2O M.W. 406.37. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/15 mg) contains:Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................15 mg. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/30 mg) contains:Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................30 mgEach Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/60 mg) contains:Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................60 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose, and magnesium stearate."
},
{
"NDCCode": "65862-642-12",
"PackageDescription": "12500 TABLET, FILM COATED in 1 BAG (65862-642-12) ",
"NDC11Code": "65862-0642-12",
"ProductNDC": "65862-642",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200916",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-05-21",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "16-SEP-20"
},
{
"NDCCode": "68016-642-12",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (68016-642-12) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "68016-0642-12",
"ProductNDC": "68016-642",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Low Dose",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110501",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Chain Drug Consortium",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110501",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief."
},
{
"NDCCode": "68428-642-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-642-12) ",
"NDC11Code": "68428-0642-12",
"ProductNDC": "68428-642",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spigelia Anthelmia",
"NonProprietaryName": "Spigelia Anthelmia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091231",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SPIGELIA ANTHELMIA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20091231",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. SPIGELIA ANTHHeadache."
},
{
"NDCCode": "72476-642-12",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (72476-642-12) ",
"NDC11Code": "72476-0642-12",
"ProductNDC": "72476-642",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190630",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Care One (Retail Business Services, LLC.)",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190630",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching."
},
{
"NDCCode": "65044-7463-1",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (65044-7463-1) > 100 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "65044-7463-01",
"ProductNDC": "65044-7463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erbitux",
"NonProprietaryName": "Cetuximab",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080104",
"MarketingCategoryName": "APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"ApplicationNumber": "BLA125084",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "CETUXIMAB",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"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": "0642-0079-03",
"PackageDescription": "3 TABLET in 1 CARTON (0642-0079-03) ",
"NDC11Code": "00642-0079-03",
"ProductNDC": "0642-0079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol Ob",
"ProprietaryNameSuffix": "Caplet",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, And Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": ".ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC",
"StrengthNumber": "30; 70; 100; 2; 12; 1; 65; 25; 18; 2.5; 1.8; 1.6; 2700; 400; 25",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151109",
"SamplePackage": "Y",
"IndicationAndUsage": "Vitafol ®-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*.",
"Description": "Each Caplet contains. Other Ingredients: microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, hydroxypropyl methylcellulose, dicalcium phosphate, acacia gum, titanium dioxide, polydextrose, starch, magnesium stearate, triacetin, modified food starch, mannitol, vitamin E alcohol, polyethylene glycol, talc, FD&C Blue #1, FD&C Blue #2."
},
{
"NDCCode": "0642-0079-08",
"PackageDescription": "4 TABLET in 1 CARTON (0642-0079-08) ",
"NDC11Code": "00642-0079-08",
"ProductNDC": "0642-0079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol Ob",
"ProprietaryNameSuffix": "Caplet",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, And Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": ".ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC",
"StrengthNumber": "30; 70; 100; 2; 12; 1; 65; 25; 18; 2.5; 1.8; 1.6; 2700; 400; 25",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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": "20021202",
"SamplePackage": "N"
},
{
"NDCCode": "0642-0092-01",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0092-01) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00642-0092-01",
"ProductNDC": "0642-0092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Plus",
"NonProprietaryName": "Omega-3 Fatty Acids, Niacin, .alpha.-tocopherol, Vitamin D, Lauric Acid, Vitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc, Copper, Iodine, Magnesium, And Folic Acid",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Everett Laboratories, Inc.",
"SubstanceName": "OMEGA-3 FATTY ACIDS; NIACIN; .ALPHA.-TOCOPHEROL; VITAMIN D; LAURIC ACID; VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC; COPPER; IODINE; MAGNESIUM; FOLIC ACID",
"StrengthNumber": "200; 15; 10; 1000; 60; 1100; 12; 1.6; 1.8; 2.5; 12; 27; 15; 2; 200; 5; 1",
"StrengthUnit": "mg/1; mg/1; [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Vitafol®-Plus 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®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.",
"Description": "Each Softgel Capsule Contains."
},
{
"NDCCode": "0642-0092-30",
"PackageDescription": "5 BLISTER PACK in 1 BOX (0642-0092-30) > 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00642-0092-30",
"ProductNDC": "0642-0092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Plus",
"NonProprietaryName": "Omega-3 Fatty Acids, Niacin, .alpha.-tocopherol, Vitamin D, Lauric Acid, Vitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc, Copper, Iodine, Magnesium, And Folic Acid",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Everett Laboratories, Inc.",
"SubstanceName": "OMEGA-3 FATTY ACIDS; NIACIN; .ALPHA.-TOCOPHEROL; VITAMIN D; LAURIC ACID; VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC; COPPER; IODINE; MAGNESIUM; FOLIC ACID",
"StrengthNumber": "200; 15; 10; 1000; 60; 1100; 12; 1.6; 1.8; 2.5; 12; 27; 15; 2; 200; 5; 1",
"StrengthUnit": "mg/1; mg/1; [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Vitafol®-Plus 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®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.",
"Description": "Each Softgel Capsule Contains."
},
{
"NDCCode": "0642-0093-01",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0093-01) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00642-0093-01",
"ProductNDC": "0642-0093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130923",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; .BETA.-CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM",
"StrengthNumber": "200; 15; 20; 1000; 1100; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; .4; .6",
"StrengthUnit": "mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-04-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0642-0093-03",
"PackageDescription": "1 BLISTER PACK in 1 BOX (0642-0093-03) / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00642-0093-03",
"ProductNDC": "0642-0093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130923",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; BETA CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM",
"StrengthNumber": "200; 15; 9; 25; 330; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; 680; 1020",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], 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": "20130923",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*. Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.",
"Description": "Amount per Capsule. Other Ingredients. Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil. Contains: Soy."
},
{
"NDCCode": "0642-0093-30",
"PackageDescription": "5 BLISTER PACK in 1 BOX (0642-0093-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00642-0093-30",
"ProductNDC": "0642-0093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130923",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; BETA CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM",
"StrengthNumber": "200; 15; 9; 25; 330; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; 680; 1020",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], 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": "20130923",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*. Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.",
"Description": "Amount per Capsule. Other Ingredients. Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil. Contains: Soy."
},
{
"NDCCode": "0642-0094-01",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (0642-0094-01) ",
"NDC11Code": "00642-0094-01",
"ProductNDC": "0642-0094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Nano",
"NonProprietaryName": "Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; LEVOMEFOLATE CALCIUM; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 12; 680; 150; 18; 1020; 2.5",
"StrengthUnit": "ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol ®-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.",
"Description": "Amount per Tablet."
},
{
"NDCCode": "0642-0094-03",
"PackageDescription": "3 TABLET, COATED in 1 BLISTER PACK (0642-0094-03) ",
"NDC11Code": "00642-0094-03",
"ProductNDC": "0642-0094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Nano",
"NonProprietaryName": "Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; LEVOMEFOLATE CALCIUM; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 12; 680; 150; 18; 1020; 2.5",
"StrengthUnit": "ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Vitafol ®-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.",
"Description": "Amount per Tablet."
},
{
"NDCCode": "0642-0094-30",
"PackageDescription": "30 TABLET, COATED in 1 BLISTER PACK (0642-0094-30) ",
"NDC11Code": "00642-0094-30",
"ProductNDC": "0642-0094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitafol",
"ProprietaryNameSuffix": "Nano",
"NonProprietaryName": "Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; IRON; IODINE",
"StrengthNumber": "1000; 2.5; .4; .6; 12; 18; 150",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N"
},
{
"NDCCode": "0642-0204-10",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (0642-0204-10) ",
"NDC11Code": "00642-0204-10",
"ProductNDC": "0642-0204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strovite Forte",
"ProprietaryNameSuffix": "Caplet",
"NonProprietaryName": "Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Pantothenic Acid, Magnesium, Zinc, Selenium, Copper, Chromium, Molybdenum, And Iron",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"EndMarketingDate": "20230113",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": ".ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CHROMIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; MOLYBDENUM; NIACIN; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC",
"StrengthNumber": "60; 500; .15; 50; 3; 50; 1; 10; 50; 20; 100; 25; 25; 20; 50; 20; 4000; 400; 15",
"StrengthUnit": "[iU]/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; [iU]/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Standardized Chemical Allergen [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": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961001",
"EndMarketingDatePackage": "20230113",
"SamplePackage": "N"
},
{
"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": "0642-3010-30",
"PackageDescription": "5 BLISTER PACK in 1 BOX (0642-3010-30) > 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "00642-3010-30",
"ProductNDC": "0642-3010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reaphirm Plant Source Dha",
"NonProprietaryName": "Prenatal Supplement",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111205",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Everett Laboratories, 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; VITAMIN E; IRON",
"StrengthNumber": "1100; 30; 1.6; 1.8; 15; 2.5; .012; 1; .15; 20; 25; 2; 1000; 200; 20; 29",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin D [CS],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0642-7464-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (0642-7464-10) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00642-7464-10",
"ProductNDC": "0642-7464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benznidazole",
"NonProprietaryName": "Benznidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180330",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209570",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "BENZNIDAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180330",
"SamplePackage": "N",
"IndicationAndUsage": "Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ( 14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.",
"Description": "Benznidazole Tablets contain benznidazole, a nitroimidazole antimicrobial. The chemical name of benznidazole is N-benzyl-2-(2-nitro-1H-imidazol-1-yl) acetamide. The empirical formula is C 12H 12N 4O 3 and the molecular weight is 260.246 g/mol. The structural formula is:. Figure 1: Benznidazole Structure. Benznidazole is a yellowish, practically crystalline powder that is practically insoluble in water, sparingly soluble in acetone and ethanol, and slightly soluble in methanol. Benznidazole Tablets are white round tablets each containing 12.5 mg or 100 mg of benznidazole, for oral use. The 100 mg white tablets are round and functionally scored twice as a cross on both sides debossed with “E” on one side of each quarter portion. The 12.5 mg white tablets are round and unscored debossed with “E” on one side. The inactive ingredients are as follows: magnesium stearate, NF; microcrystalline cellulose, NF; monohydrate lactose, NF; pre-gelatinized corn starch, NF; and sodium croscarmellose, NF."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0642-7463-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE</PackageDescription>
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<ProductNDC>0642-7463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>BENZNIDAZOLE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ( 14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.</IndicationAndUsage>
<Description>Benznidazole Tablets contain benznidazole, a nitroimidazole antimicrobial. The chemical name of benznidazole is N-benzyl-2-(2-nitro-1H-imidazol-1-yl) acetamide. The empirical formula is C 12H 12N 4O 3 and the molecular weight is 260.246 g/mol. The structural formula is:. Figure 1: Benznidazole Structure. Benznidazole is a yellowish, practically crystalline powder that is practically insoluble in water, sparingly soluble in acetone and ethanol, and slightly soluble in methanol. Benznidazole Tablets are white round tablets each containing 12.5 mg or 100 mg of benznidazole, for oral use. The 100 mg white tablets are round and functionally scored twice as a cross on both sides debossed with “E” on one side of each quarter portion. The 12.5 mg white tablets are round and unscored debossed with “E” on one side. The inactive ingredients are as follows: magnesium stearate, NF; microcrystalline cellulose, NF; monohydrate lactose, NF; pre-gelatinized corn starch, NF; and sodium croscarmellose, NF.</Description>
</NDC>
<NDC>
<NDCCode>0642-0072-12</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOX (0642-0072-12) </PackageDescription>
<NDC11Code>00642-0072-12</NDC11Code>
<ProductNDC>0642-0072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
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<NonProprietaryName>Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, And Iron</NonProprietaryName>
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<EndMarketingDate>20230113</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D</SubstanceName>
<StrengthNumber>10; 60; 125; 5; 1; 27; 15; 15; 1.8; 1.1; 6000; 400</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19850501</StartMarketingDatePackage>
<EndMarketingDatePackage>20230113</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0642-0079-12</NDCCode>
<PackageDescription>100 TABLET in 1 CARTON (0642-0079-12) </PackageDescription>
<NDC11Code>00642-0079-12</NDC11Code>
<ProductNDC>0642-0079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol Ob</ProprietaryName>
<ProprietaryNameSuffix>Caplet</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, And Copper</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC</SubstanceName>
<StrengthNumber>30; 70; 100; 2; 12; 1; 65; 25; 18; 2.5; 1.8; 1.6; 2700; 400; 25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol ®-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*.</IndicationAndUsage>
<Description>Each Caplet contains. Other Ingredients: microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, hydroxypropyl methylcellulose, dicalcium phosphate, acacia gum, titanium dioxide, polydextrose, starch, magnesium stearate, triacetin, modified food starch, mannitol, vitamin E alcohol, polyethylene glycol, talc, FD&C Blue #1, FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>11523-0642-1</NDCCode>
<PackageDescription>1 CELLO PACK in 1 CARTON (11523-0642-1) > 12 DISC in 1 CELLO PACK</PackageDescription>
<NDC11Code>11523-0642-01</NDC11Code>
<ProductNDC>11523-0642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr. Scholls</ProprietaryName>
<ProprietaryNameSuffix>Clear Away Wrt Removers With Duragel Technology</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>DISC</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<EndMarketingDate>20220131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358B</ApplicationNumber>
<LabelerName>Bayer Health Care LLC.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<EndMarketingDatePackage>20220131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21130-642-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (21130-642-12) </PackageDescription>
<NDC11Code>21130-0642-12</NDC11Code>
<ProductNDC>21130-642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190331</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Safeway, Inc.</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190331</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-642-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (49035-642-12) </PackageDescription>
<NDC11Code>49035-0642-12</NDC11Code>
<ProductNDC>49035-642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190331</StartMarketingDate>
<EndMarketingDate>20250331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190331</StartMarketingDatePackage>
<EndMarketingDatePackage>20250331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64850-642-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (64850-642-12) </PackageDescription>
<NDC11Code>64850-0642-12</NDC11Code>
<ProductNDC>64850-642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212418</ApplicationNumber>
<LabelerName>Elite Laboratories, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including acetaminophen and codeine phosphate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Codeine phosphate, USP, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C18H21NO3H3PO4½H2O M.W. 406.37. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/15 mg) contains:Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................15 mg. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/30 mg) contains:Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................30 mgEach Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/60 mg) contains:Acetaminophen, USP...........................300 mgCodeine Phosphate, USP.......................60 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>65862-642-12</NDCCode>
<PackageDescription>12500 TABLET, FILM COATED in 1 BAG (65862-642-12) </PackageDescription>
<NDC11Code>65862-0642-12</NDC11Code>
<ProductNDC>65862-642</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200916</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-21</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-SEP-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68016-642-12</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (68016-642-12) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68016-0642-12</NDC11Code>
<ProductNDC>68016-642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<ProprietaryNameSuffix>Low Dose</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110501</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Chain Drug Consortium</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110501</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-642-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-642-12) </PackageDescription>
<NDC11Code>68428-0642-12</NDC11Code>
<ProductNDC>68428-642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spigelia Anthelmia</ProprietaryName>
<NonProprietaryName>Spigelia Anthelmia</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091231</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SPIGELIA ANTHELMIA</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. SPIGELIA ANTHHeadache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72476-642-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (72476-642-12) </PackageDescription>
<NDC11Code>72476-0642-12</NDC11Code>
<ProductNDC>72476-642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190630</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Care One (Retail Business Services, LLC.)</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190630</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65044-7463-1</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (65044-7463-1) > 100 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>65044-7463-01</NDC11Code>
<ProductNDC>65044-7463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erbitux</ProprietaryName>
<NonProprietaryName>Cetuximab</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080104</StartMarketingDate>
<MarketingCategoryName>APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<ApplicationNumber>BLA125084</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>CETUXIMAB</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</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>0642-0079-03</NDCCode>
<PackageDescription>3 TABLET in 1 CARTON (0642-0079-03) </PackageDescription>
<NDC11Code>00642-0079-03</NDC11Code>
<ProductNDC>0642-0079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol Ob</ProprietaryName>
<ProprietaryNameSuffix>Caplet</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, And Copper</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC</SubstanceName>
<StrengthNumber>30; 70; 100; 2; 12; 1; 65; 25; 18; 2.5; 1.8; 1.6; 2700; 400; 25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151109</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Vitafol ®-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*.</IndicationAndUsage>
<Description>Each Caplet contains. Other Ingredients: microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, hydroxypropyl methylcellulose, dicalcium phosphate, acacia gum, titanium dioxide, polydextrose, starch, magnesium stearate, triacetin, modified food starch, mannitol, vitamin E alcohol, polyethylene glycol, talc, FD&C Blue #1, FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>0642-0079-08</NDCCode>
<PackageDescription>4 TABLET in 1 CARTON (0642-0079-08) </PackageDescription>
<NDC11Code>00642-0079-08</NDC11Code>
<ProductNDC>0642-0079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol Ob</ProprietaryName>
<ProprietaryNameSuffix>Caplet</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, And Copper</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC</SubstanceName>
<StrengthNumber>30; 70; 100; 2; 12; 1; 65; 25; 18; 2.5; 1.8; 1.6; 2700; 400; 25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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>20021202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0642-0092-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0092-01) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0092-01</NDC11Code>
<ProductNDC>0642-0092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
<NonProprietaryName>Omega-3 Fatty Acids, Niacin, .alpha.-tocopherol, Vitamin D, Lauric Acid, Vitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc, Copper, Iodine, Magnesium, And Folic Acid</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Everett Laboratories, Inc.</LabelerName>
<SubstanceName>OMEGA-3 FATTY ACIDS; NIACIN; .ALPHA.-TOCOPHEROL; VITAMIN D; LAURIC ACID; VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC; COPPER; IODINE; MAGNESIUM; FOLIC ACID</SubstanceName>
<StrengthNumber>200; 15; 10; 1000; 60; 1100; 12; 1.6; 1.8; 2.5; 12; 27; 15; 2; 200; 5; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitafol®-Plus 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®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.</IndicationAndUsage>
<Description>Each Softgel Capsule Contains.</Description>
</NDC>
<NDC>
<NDCCode>0642-0092-30</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 BOX (0642-0092-30) > 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0092-30</NDC11Code>
<ProductNDC>0642-0092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
<NonProprietaryName>Omega-3 Fatty Acids, Niacin, .alpha.-tocopherol, Vitamin D, Lauric Acid, Vitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc, Copper, Iodine, Magnesium, And Folic Acid</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Everett Laboratories, Inc.</LabelerName>
<SubstanceName>OMEGA-3 FATTY ACIDS; NIACIN; .ALPHA.-TOCOPHEROL; VITAMIN D; LAURIC ACID; VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC; COPPER; IODINE; MAGNESIUM; FOLIC ACID</SubstanceName>
<StrengthNumber>200; 15; 10; 1000; 60; 1100; 12; 1.6; 1.8; 2.5; 12; 27; 15; 2; 200; 5; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitafol®-Plus 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®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.</IndicationAndUsage>
<Description>Each Softgel Capsule Contains.</Description>
</NDC>
<NDC>
<NDCCode>0642-0093-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0093-01) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0093-01</NDC11Code>
<ProductNDC>0642-0093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130923</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; .BETA.-CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM</SubstanceName>
<StrengthNumber>200; 15; 20; 1000; 1100; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; .4; .6</StrengthNumber>
<StrengthUnit>mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0642-0093-03</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (0642-0093-03) / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0093-03</NDC11Code>
<ProductNDC>0642-0093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130923</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; BETA CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM</SubstanceName>
<StrengthNumber>200; 15; 9; 25; 330; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; 680; 1020</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/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], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], 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>20130923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*. Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.</IndicationAndUsage>
<Description>Amount per Capsule. Other Ingredients. Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil. Contains: Soy.</Description>
</NDC>
<NDC>
<NDCCode>0642-0093-30</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 BOX (0642-0093-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-0093-30</NDC11Code>
<ProductNDC>0642-0093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130923</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; BETA CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM</SubstanceName>
<StrengthNumber>200; 15; 9; 25; 330; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; 680; 1020</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/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], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], 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>20130923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol ® Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*. Vitafol ® Ultra does not contain fish, fish oils, fish proteins or fish byproducts.</IndicationAndUsage>
<Description>Amount per Capsule. Other Ingredients. Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue #1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil. Contains: Soy.</Description>
</NDC>
<NDC>
<NDCCode>0642-0094-01</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (0642-0094-01) </PackageDescription>
<NDC11Code>00642-0094-01</NDC11Code>
<ProductNDC>0642-0094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Nano</ProprietaryNameSuffix>
<NonProprietaryName>Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; LEVOMEFOLATE CALCIUM; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 12; 680; 150; 18; 1020; 2.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol ®-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.</IndicationAndUsage>
<Description>Amount per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>0642-0094-03</NDCCode>
<PackageDescription>3 TABLET, COATED in 1 BLISTER PACK (0642-0094-03) </PackageDescription>
<NDC11Code>00642-0094-03</NDC11Code>
<ProductNDC>0642-0094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Nano</ProprietaryNameSuffix>
<NonProprietaryName>Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; LEVOMEFOLATE CALCIUM; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 12; 680; 150; 18; 1020; 2.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vitafol ®-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.</IndicationAndUsage>
<Description>Amount per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>0642-0094-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BLISTER PACK (0642-0094-30) </PackageDescription>
<NDC11Code>00642-0094-30</NDC11Code>
<ProductNDC>0642-0094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitafol</ProprietaryName>
<ProprietaryNameSuffix>Nano</ProprietaryNameSuffix>
<NonProprietaryName>Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; IRON; IODINE</SubstanceName>
<StrengthNumber>1000; 2.5; .4; .6; 12; 18; 150</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0642-0204-10</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (0642-0204-10) </PackageDescription>
<NDC11Code>00642-0204-10</NDC11Code>
<ProductNDC>0642-0204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strovite Forte</ProprietaryName>
<ProprietaryNameSuffix>Caplet</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Pantothenic Acid, Magnesium, Zinc, Selenium, Copper, Chromium, Molybdenum, And Iron</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<EndMarketingDate>20230113</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CHROMIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; MOLYBDENUM; NIACIN; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC</SubstanceName>
<StrengthNumber>60; 500; .15; 50; 3; 50; 1; 10; 50; 20; 100; 25; 25; 20; 50; 20; 4000; 400; 15</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; [iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Standardized Chemical Allergen [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>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<EndMarketingDatePackage>20230113</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>0642-3010-30</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 BOX (0642-3010-30) > 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00642-3010-30</NDC11Code>
<ProductNDC>0642-3010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reaphirm Plant Source Dha</ProprietaryName>
<NonProprietaryName>Prenatal Supplement</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111205</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Everett Laboratories, 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; VITAMIN E; IRON</SubstanceName>
<StrengthNumber>1100; 30; 1.6; 1.8; 15; 2.5; .012; 1; .15; 20; 25; 2; 1000; 200; 20; 29</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin D [CS],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0642-7464-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0642-7464-10) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00642-7464-10</NDC11Code>
<ProductNDC>0642-7464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benznidazole</ProprietaryName>
<NonProprietaryName>Benznidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180330</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209570</ApplicationNumber>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>BENZNIDAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ( 14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.</IndicationAndUsage>
<Description>Benznidazole Tablets contain benznidazole, a nitroimidazole antimicrobial. The chemical name of benznidazole is N-benzyl-2-(2-nitro-1H-imidazol-1-yl) acetamide. The empirical formula is C 12H 12N 4O 3 and the molecular weight is 260.246 g/mol. The structural formula is:. Figure 1: Benznidazole Structure. Benznidazole is a yellowish, practically crystalline powder that is practically insoluble in water, sparingly soluble in acetone and ethanol, and slightly soluble in methanol. Benznidazole Tablets are white round tablets each containing 12.5 mg or 100 mg of benznidazole, for oral use. The 100 mg white tablets are round and functionally scored twice as a cross on both sides debossed with “E” on one side of each quarter portion. The 12.5 mg white tablets are round and unscored debossed with “E” on one side. The inactive ingredients are as follows: magnesium stearate, NF; microcrystalline cellulose, NF; monohydrate lactose, NF; pre-gelatinized corn starch, NF; and sodium croscarmellose, NF.</Description>
</NDC>
</NDCList>