{
"NDC": [
{
"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": "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": "0642-0072-12",
"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": "0642-7463-12",
"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": "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": "20261231",
"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": "0132-0079-12",
"PackageDescription": "12 SUPPOSITORY in 1 JAR (0132-0079-12) ",
"NDC11Code": "00132-0079-12",
"ProductNDC": "0132-0079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fleet",
"NonProprietaryName": "Glycerin",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "19841101",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "C.B. Fleet Company, Inc.",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19841101",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N"
},
{
"NDCCode": "0280-0079-01",
"PackageDescription": "12 PACKET in 1 CARTON (0280-0079-01) / 2 TABLET, EFFERVESCENT in 1 PACKET",
"NDC11Code": "00280-0079-01",
"ProductNDC": "0280-0079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Heartburn Relief Extra Strength",
"NonProprietaryName": "Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Bayer Healthcare LLC",
"SubstanceName": "SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE",
"StrengthNumber": "1976; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the relief of : 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "11014-0079-1",
"PackageDescription": "2 POUCH in 1 CARTON (11014-0079-1) > 12 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "11014-0079-01",
"ProductNDC": "11014-0079",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120820",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/3mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "17856-0079-1",
"PackageDescription": "12.5 mL in 1 CUP (17856-0079-1) ",
"NDC11Code": "17856-0079-01",
"ProductNDC": "17856-0079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19960426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040119",
"LabelerName": "ATLANTIC BIOLOGICALS COPR.",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "120; 12",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210112",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.",
"Description": "Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 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. Each 5 mL, for oral administration, contains. Acetaminophen 120 mg. Codeine Phosphate 12 mg. (Warning: May be habit forming). Alcohol 7%. In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose."
},
{
"NDCCode": "17856-0079-4",
"PackageDescription": "12 mL in 1 CUP (17856-0079-4) ",
"NDC11Code": "17856-0079-04",
"ProductNDC": "17856-0079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19960426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040119",
"LabelerName": "ATLANTIC BIOLOGICALS COPR.",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "120; 12",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210112",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.",
"Description": "Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 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. Each 5 mL, for oral administration, contains. Acetaminophen 120 mg. Codeine Phosphate 12 mg. (Warning: May be habit forming). Alcohol 7%. In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose."
},
{
"NDCCode": "21695-079-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (21695-079-12)",
"NDC11Code": "21695-0079-12",
"ProductNDC": "21695-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19760818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085123",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate."
},
{
"NDCCode": "69509-079-12",
"PackageDescription": "125 g in 1 BOTTLE, PUMP (69509-079-12)",
"NDC11Code": "69509-0079-12",
"ProductNDC": "69509-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primo Apf",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "DENTAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Tri State Dental Supply",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5375",
"StrengthUnit": "g/125g",
"Status": "Deprecated",
"LastUpdate": "2019-02-13",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "70377-079-12",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (70377-079-12) ",
"NDC11Code": "70377-0079-12",
"ProductNDC": "70377-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216436",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca∙3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solution of pH 4.0 and acetonitrile. Atorvastatin calcium is very slightly soluble in water, in pH 7.4 phosphate buffer, and; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, macrogol, titanium dioxide and talc) and polysorbate 80. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Dissolution meets USP test 4."
},
{
"NDCCode": "70677-0079-1",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (70677-0079-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70677-0079-01",
"ProductNDC": "70677-0079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190821",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat."
},
{
"NDCCode": "71205-079-12",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (71205-079-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "71205-0079-12",
"ProductNDC": "71205-079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N",
"IndicationAndUsage": "controls symptoms of diarrhea, including Travelers’ Diarrhea."
},
{
"NDCCode": "71930-079-12",
"PackageDescription": "100 TABLET in 1 BOTTLE (71930-079-12) ",
"NDC11Code": "71930-0079-12",
"ProductNDC": "71930-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217160",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221007",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone Tablets are indicated in the following conditions.",
"Description": "Hydrocortisone Tablets, USPcontain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USPare available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: calcium stearate, corn starch, lactose monohydrate, sorbic acid, sucrose. Meets USP Dissolution Test 2. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli."
},
{
"NDCCode": "73212-079-12",
"PackageDescription": "100 g in 1 BOTTLE (73212-079-12) ",
"NDC11Code": "73212-0079-12",
"ProductNDC": "73212-079",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231023",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Biopeptek Co., Ltd.",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-01-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "23-OCT-23"
},
{
"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": "20261231",
"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": "20261231",
"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": "0642-0092-01",
"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."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>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>0642-0072-12</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>
<ProprietaryNameSuffix>Caplet</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Vitamin D, .alpha.-tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, And Iron</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19850501</StartMarketingDate>
<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>0642-7463-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00642-7463-12</NDC11Code>
<ProductNDC>0642-7463</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>12.5</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>
<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>20261231</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>0132-0079-12</NDCCode>
<PackageDescription>12 SUPPOSITORY in 1 JAR (0132-0079-12) </PackageDescription>
<NDC11Code>00132-0079-12</NDC11Code>
<ProductNDC>0132-0079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fleet</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19841101</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>C.B. Fleet Company, Inc.</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19841101</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0280-0079-01</NDCCode>
<PackageDescription>12 PACKET in 1 CARTON (0280-0079-01) / 2 TABLET, EFFERVESCENT in 1 PACKET</PackageDescription>
<NDC11Code>00280-0079-01</NDC11Code>
<ProductNDC>0280-0079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Heartburn Relief Extra Strength</ProprietaryName>
<NonProprietaryName>Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Bayer Healthcare LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE</SubstanceName>
<StrengthNumber>1976; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the relief of : 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11014-0079-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (11014-0079-1) > 12 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>11014-0079-01</NDC11Code>
<ProductNDC>11014-0079</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120820</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>17856-0079-1</NDCCode>
<PackageDescription>12.5 mL in 1 CUP (17856-0079-1) </PackageDescription>
<NDC11Code>17856-0079-01</NDC11Code>
<ProductNDC>17856-0079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040119</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS COPR.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>120; 12</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 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. Each 5 mL, for oral administration, contains. Acetaminophen 120 mg. Codeine Phosphate 12 mg. (Warning: May be habit forming). Alcohol 7%. In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>17856-0079-4</NDCCode>
<PackageDescription>12 mL in 1 CUP (17856-0079-4) </PackageDescription>
<NDC11Code>17856-0079-04</NDC11Code>
<ProductNDC>17856-0079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040119</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS COPR.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>120; 12</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 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. Each 5 mL, for oral administration, contains. Acetaminophen 120 mg. Codeine Phosphate 12 mg. (Warning: May be habit forming). Alcohol 7%. In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>21695-079-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (21695-079-12)</PackageDescription>
<NDC11Code>21695-0079-12</NDC11Code>
<ProductNDC>21695-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085123</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>69509-079-12</NDCCode>
<PackageDescription>125 g in 1 BOTTLE, PUMP (69509-079-12)</PackageDescription>
<NDC11Code>69509-0079-12</NDC11Code>
<ProductNDC>69509-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primo Apf</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Tri State Dental Supply</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5375</StrengthNumber>
<StrengthUnit>g/125g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-13</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70377-079-12</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70377-079-12) </PackageDescription>
<NDC11Code>70377-0079-12</NDC11Code>
<ProductNDC>70377-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216436</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca∙3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solution of pH 4.0 and acetonitrile. Atorvastatin calcium is very slightly soluble in water, in pH 7.4 phosphate buffer, and; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, macrogol, titanium dioxide and talc) and polysorbate 80. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Dissolution meets USP test 4.</Description>
</NDC>
<NDC>
<NDCCode>70677-0079-1</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (70677-0079-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70677-0079-01</NDC11Code>
<ProductNDC>70677-0079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunmark Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Strategic Sourcing Services LLC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-079-12</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (71205-079-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>71205-0079-12</NDC11Code>
<ProductNDC>71205-079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>controls symptoms of diarrhea, including Travelers’ Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71930-079-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71930-079-12) </PackageDescription>
<NDC11Code>71930-0079-12</NDC11Code>
<ProductNDC>71930-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217160</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>Hydrocortisone Tablets, USPcontain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USPare available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: calcium stearate, corn starch, lactose monohydrate, sorbic acid, sucrose. Meets USP Dissolution Test 2. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>73212-079-12</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (73212-079-12) </PackageDescription>
<NDC11Code>73212-0079-12</NDC11Code>
<ProductNDC>73212-079</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231023</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-OCT-23</StartMarketingDatePackage>
</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>20261231</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>20261231</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>0642-0092-01</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>
</NDCList>