{
"NDC": [
{
"NDCCode": "44946-1045-4",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (44946-1045-4) ",
"NDC11Code": "44946-1045-04",
"ProductNDC": "44946-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatal Plus Multivitamin",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, And Cupric Oxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"EndMarketingDate": "20180410",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130401",
"EndMarketingDatePackage": "20180410",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1045-1",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (44946-1045-1) ",
"NDC11Code": "44946-1045-01",
"ProductNDC": "44946-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatal Plus Multivitamin",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, And Cupric Oxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"EndMarketingDate": "20180410",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130401",
"EndMarketingDatePackage": "20180410",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1045-9",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (44946-1045-9) ",
"NDC11Code": "44946-1045-09",
"ProductNDC": "44946-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatal Plus Multivitamin",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, And Cupric Oxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"EndMarketingDate": "20180410",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130401",
"EndMarketingDatePackage": "20180410",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1045-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1045-01) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1045-01",
"ProductNDC": "0409-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pemetrexed",
"NonProprietaryName": "Pemetrexed",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214218",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "PEMETREXED DISODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220627",
"SamplePackage": "N",
"IndicationAndUsage": "Pemetrexed Injection is a folate analog metabolic inhibitor indicated: 1 In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1), 2 As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1), 4 Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1), 5 Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium (2.5 H2O), has the chemical name N-[[4-[2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]phenyl]carbonyl]-L-glutamic acid disodium, hemipentahydrate with a molecular formula of C20H19N5Na2O6 ∙2.5H2O and a molecular weight of 516.41. The structural formula is as follows. Pemetrexed Injection, 100 mg/4 mL, 500 mg/20 mL, and 1 g/40 mL are supplied as a sterile, preservative-free, clear, colorless to pale yellow ready-to-dilute solution in a single-dose vial for intravenous infusion. Each milliliter (mL) contains 25 mg pemetrexed (equivalent to 27.57 mg pemetrexed disodium), 1.2 mg monothioglycerol, water for injection and may contain sodium hydroxide for pH adjustment."
},
{
"NDCCode": "11584-1045-4",
"PackageDescription": "120 mL in 1 BOTTLE (11584-1045-4)",
"NDC11Code": "11584-1045-04",
"ProductNDC": "11584-1045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Despec",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20021101",
"EndMarketingDate": "20150830",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "International Ethical Laboratories, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "15; 100; 5",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "17856-1045-3",
"PackageDescription": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-3) / 5 mL in 1 SYRINGE (17856-1045-4) ",
"NDC11Code": "17856-1045-03",
"ProductNDC": "17856-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203621",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240718",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.",
"Description": "Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose."
},
{
"NDCCode": "36987-1045-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1045-4)",
"NDC11Code": "36987-1045-04",
"ProductNDC": "36987-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gerbil Epithelium",
"NonProprietaryName": "Gerbil Epithelium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "MERIONES UNGUICULATUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "71335-1045-4",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71335-1045-4) ",
"NDC11Code": "71335-1045-04",
"ProductNDC": "71335-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19930501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063065",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2019-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each Minocycline Hydrochloride Capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn). The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 100 mg capsule shell also contains black iron oxide."
},
{
"NDCCode": "85512-1045-4",
"PackageDescription": "50 g in 1 BOTTLE (85512-1045-4) ",
"NDC11Code": "85512-1045-04",
"ProductNDC": "85512-1045",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Larazotide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Qinzeyuan Biotechnology Co., Ltd",
"SubstanceName": "LARAZOTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JUN-25"
},
{
"NDCCode": "44946-1012-4",
"PackageDescription": "4 BOX in 1 BOX (44946-1012-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1012-04",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1012-5",
"PackageDescription": "4 BOX in 1 BOX (44946-1012-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1012-05",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1013-4",
"PackageDescription": "4 BOX in 1 BOX (44946-1013-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1013-04",
"ProductNDC": "44946-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1013-5",
"PackageDescription": "4 BOX in 1 BOX (44946-1013-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1013-05",
"ProductNDC": "44946-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1014-4",
"PackageDescription": "4 BOX in 1 BOX (44946-1014-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1014-04",
"ProductNDC": "44946-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1014-5",
"PackageDescription": "4 BOX in 1 BOX (44946-1014-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1014-05",
"ProductNDC": "44946-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1046-4",
"PackageDescription": "400 TABLET in 1 BOTTLE, PLASTIC (44946-1046-4)",
"NDC11Code": "44946-1046-04",
"ProductNDC": "44946-1046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatal Vitamin",
"ProprietaryNameSuffix": "Plus Vitamin A",
"NonProprietaryName": ".alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE",
"StrengthNumber": "15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Each PNV tablet contains."
},
{
"NDCCode": "44946-1012-6",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1012-6)",
"NDC11Code": "44946-1012-06",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1012-7",
"PackageDescription": "7 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1012-7)",
"NDC11Code": "44946-1012-07",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1013-6",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1013-6)",
"NDC11Code": "44946-1013-06",
"ProductNDC": "44946-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1014-6",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1014-6)",
"NDC11Code": "44946-1014-06",
"ProductNDC": "44946-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1020-5",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (44946-1020-5) ",
"NDC11Code": "44946-1020-05",
"ProductNDC": "44946-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc-fluoride",
"NonProprietaryName": "Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111207",
"EndMarketingDate": "20180220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc.",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111207",
"EndMarketingDatePackage": "20180220",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1021-5",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (44946-1021-5) ",
"NDC11Code": "44946-1021-05",
"ProductNDC": "44946-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc-fluoride",
"NonProprietaryName": "Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111207",
"EndMarketingDate": "20180220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc.",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111207",
"EndMarketingDatePackage": "20180220",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1022-5",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (44946-1022-5)",
"NDC11Code": "44946-1022-05",
"ProductNDC": "44946-1022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc-fluoride",
"NonProprietaryName": "Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1023-1",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1023-1) ",
"NDC11Code": "44946-1023-01",
"ProductNDC": "44946-1023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multivitamin With Fluoride",
"NonProprietaryName": ".alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111220",
"EndMarketingDate": "20180306",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
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<ProductNDC>44946-1045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Plus Multivitamin</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<EndMarketingDate>20180410</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<EndMarketingDatePackage>20180410</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1045-9</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (44946-1045-9) </PackageDescription>
<NDC11Code>44946-1045-09</NDC11Code>
<ProductNDC>44946-1045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Plus Multivitamin</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<EndMarketingDate>20180410</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<EndMarketingDatePackage>20180410</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1045-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1045-01) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-1045-01</NDC11Code>
<ProductNDC>0409-1045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pemetrexed</ProprietaryName>
<NonProprietaryName>Pemetrexed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214218</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>PEMETREXED DISODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pemetrexed Injection is a folate analog metabolic inhibitor indicated: 1 In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1), 2 As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1), 4 Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1), 5 Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium (2.5 H2O), has the chemical name N-[[4-[2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]phenyl]carbonyl]-L-glutamic acid disodium, hemipentahydrate with a molecular formula of C20H19N5Na2O6 ∙2.5H2O and a molecular weight of 516.41. The structural formula is as follows. Pemetrexed Injection, 100 mg/4 mL, 500 mg/20 mL, and 1 g/40 mL are supplied as a sterile, preservative-free, clear, colorless to pale yellow ready-to-dilute solution in a single-dose vial for intravenous infusion. Each milliliter (mL) contains 25 mg pemetrexed (equivalent to 27.57 mg pemetrexed disodium), 1.2 mg monothioglycerol, water for injection and may contain sodium hydroxide for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>11584-1045-4</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (11584-1045-4)</PackageDescription>
<NDC11Code>11584-1045-04</NDC11Code>
<ProductNDC>11584-1045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Despec</ProprietaryName>
<ProprietaryNameSuffix>Dm</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021101</StartMarketingDate>
<EndMarketingDate>20150830</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>International Ethical Laboratories, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 100; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>17856-1045-3</NDCCode>
<PackageDescription>48 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-3) / 5 mL in 1 SYRINGE (17856-1045-4) </PackageDescription>
<NDC11Code>17856-1045-03</NDC11Code>
<ProductNDC>17856-1045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203621</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.</IndicationAndUsage>
<Description>Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula. C 47H 75NO 17 MW 926.13. Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>36987-1045-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1045-4)</PackageDescription>
<NDC11Code>36987-1045-04</NDC11Code>
<ProductNDC>36987-1045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gerbil Epithelium</ProprietaryName>
<NonProprietaryName>Gerbil Epithelium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>MERIONES UNGUICULATUS SKIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>71335-1045-4</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71335-1045-4) </PackageDescription>
<NDC11Code>71335-1045-04</NDC11Code>
<ProductNDC>71335-1045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063065</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Each Minocycline Hydrochloride Capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn). The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 100 mg capsule shell also contains black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>85512-1045-4</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (85512-1045-4) </PackageDescription>
<NDC11Code>85512-1045-04</NDC11Code>
<ProductNDC>85512-1045</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Larazotide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Qinzeyuan Biotechnology Co., Ltd</LabelerName>
<SubstanceName>LARAZOTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>44946-1012-4</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1012-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1012-04</NDC11Code>
<ProductNDC>44946-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1012-5</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1012-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1012-05</NDC11Code>
<ProductNDC>44946-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1013-4</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1013-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1013-04</NDC11Code>
<ProductNDC>44946-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1013-5</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1013-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1013-05</NDC11Code>
<ProductNDC>44946-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1014-4</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1014-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1014-04</NDC11Code>
<ProductNDC>44946-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1014-5</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1014-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1014-05</NDC11Code>
<ProductNDC>44946-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1046-4</NDCCode>
<PackageDescription>400 TABLET in 1 BOTTLE, PLASTIC (44946-1046-4)</PackageDescription>
<NDC11Code>44946-1046-04</NDC11Code>
<ProductNDC>44946-1046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Vitamin</ProprietaryName>
<ProprietaryNameSuffix>Plus Vitamin A</ProprietaryNameSuffix>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Each PNV tablet contains.</Description>
</NDC>
<NDC>
<NDCCode>44946-1012-6</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1012-6)</PackageDescription>
<NDC11Code>44946-1012-06</NDC11Code>
<ProductNDC>44946-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1012-7</NDCCode>
<PackageDescription>7 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1012-7)</PackageDescription>
<NDC11Code>44946-1012-07</NDC11Code>
<ProductNDC>44946-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1013-6</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1013-6)</PackageDescription>
<NDC11Code>44946-1013-06</NDC11Code>
<ProductNDC>44946-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1014-6</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1014-6)</PackageDescription>
<NDC11Code>44946-1014-06</NDC11Code>
<ProductNDC>44946-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1020-5</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (44946-1020-5) </PackageDescription>
<NDC11Code>44946-1020-05</NDC11Code>
<ProductNDC>44946-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc-fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<EndMarketingDate>20180220</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111207</StartMarketingDatePackage>
<EndMarketingDatePackage>20180220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1021-5</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (44946-1021-5) </PackageDescription>
<NDC11Code>44946-1021-05</NDC11Code>
<ProductNDC>44946-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc-fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<EndMarketingDate>20180220</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111207</StartMarketingDatePackage>
<EndMarketingDatePackage>20180220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1022-5</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (44946-1022-5)</PackageDescription>
<NDC11Code>44946-1022-05</NDC11Code>
<ProductNDC>44946-1022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc-fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1023-1</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1023-1) </PackageDescription>
<NDC11Code>44946-1023-01</NDC11Code>
<ProductNDC>44946-1023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<EndMarketingDate>20180306</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D</SubstanceName>
<StrengthNumber>15; 60; 4.5; .25; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111220</StartMarketingDatePackage>
<EndMarketingDatePackage>20180306</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1024-1</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1024-1) </PackageDescription>
<NDC11Code>44946-1024-01</NDC11Code>
<ProductNDC>44946-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<EndMarketingDate>20180306</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D</SubstanceName>
<StrengthNumber>15; 60; 4.5; .5; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111220</StartMarketingDatePackage>
<EndMarketingDatePackage>20180306</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1025-1</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1025-1) </PackageDescription>
<NDC11Code>44946-1025-01</NDC11Code>
<ProductNDC>44946-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<EndMarketingDate>20180306</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D</SubstanceName>
<StrengthNumber>15; 60; 4.5; 1; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111220</StartMarketingDatePackage>
<EndMarketingDatePackage>20180306</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1046-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (44946-1046-0)</PackageDescription>
<NDC11Code>44946-1046-00</NDC11Code>
<ProductNDC>44946-1046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Vitamin</ProprietaryName>
<ProprietaryNameSuffix>Plus Vitamin A</ProprietaryNameSuffix>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Each PNV tablet contains.</Description>
</NDC>
<NDC>
<NDCCode>44946-1046-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (44946-1046-2)</PackageDescription>
<NDC11Code>44946-1046-02</NDC11Code>
<ProductNDC>44946-1046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Vitamin</ProprietaryName>
<ProprietaryNameSuffix>Plus Vitamin A</ProprietaryNameSuffix>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Each PNV tablet contains.</Description>
</NDC>
<NDC>
<NDCCode>44946-2005-8</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, DROPPER (44946-2005-8)</PackageDescription>
<NDC11Code>44946-2005-08</NDC11Code>
<ProductNDC>44946-2005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin Drops With Fluoride</ProprietaryName>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Cholecalciferol, Tocopherol, Thiamine Ion, Riboflavin, Niacinamide, Pyridoxine, Cyanocobalamin, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company, Inc.</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE ION; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; CYANOCOBALAMIN; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1500; 35; 400; 5; .5; .6; 8; .4; 2; .25</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-26</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-2006-8</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, DROPPER (44946-2006-8) </PackageDescription>
<NDC11Code>44946-2006-08</NDC11Code>
<ProductNDC>44946-2006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin Drops With Fluoride</ProprietaryName>
<NonProprietaryName>Vitamin A, Ascorbic Acid, Cholecalciferol, Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Cyanocobalamin, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<EndMarketingDate>20180313</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company, Inc.</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; CYANOCOBALAMIN; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1500; 35; 400; 5; .5; .6; 8; .4; 2; .5</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170410</StartMarketingDatePackage>
<EndMarketingDatePackage>20180313</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>