phytomenadione 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2843 84-80-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vitamin K1
  • phytomenadione
  • vitamin K
  • phytonadione
  • phytylmenadione
  • phytylmenaquinone
  • phylloquinone
A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.
  • Molecular weight: 450.71
  • Formula: C31H46O2
  • CLOGP: 11.69
  • LIPINSKI: 1
  • HAC: 2
  • HDO: 0
  • TPSA: 34.14
  • ALOGS: -6.88
  • ROTB: 14

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O
20 mg P

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.32 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.60 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 18, 2000 FDA SANDOZ

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 199.28 14.53 67 8178 7842 50589037
International normalised ratio increased 71.58 14.53 58 8187 43094 50553785
Multiple organ dysfunction syndrome 52.36 14.53 52 8193 50285 50546594
Cystic fibrosis 51.91 14.53 19 8226 2845 50594034
Ascites 46.77 14.53 42 8203 35819 50561060
Renal vascular thrombosis 46.51 14.53 8 8237 46 50596833
Coagulopathy 45.17 14.53 31 8214 17913 50578966
Factor V inhibition 37.08 14.53 8 8237 168 50596711
Injury associated with device 36.31 14.53 15 8230 3102 50593777
Cholestasis 35.61 14.53 31 8214 25370 50571509
Sepsis 33.92 14.53 70 8175 132855 50464024
Osteochondritis 30.00 14.53 5 8240 23 50596856
Haematemesis 27.63 14.53 28 8217 27697 50569182
Intestinal dilatation 27.58 14.53 10 8235 1458 50595421
Pancreatitis chronic 26.93 14.53 11 8234 2209 50594670
Thrombocytopenia 26.62 14.53 62 8183 127611 50469268
Superior sagittal sinus thrombosis 26.04 14.53 8 8237 699 50596180
Hepatic failure 25.80 14.53 29 8216 32254 50564625
Haemorrhage neonatal 25.80 14.53 5 8240 60 50596819
Premature baby 24.93 14.53 22 8223 18315 50578564
Transverse sinus thrombosis 23.94 14.53 7 8238 517 50596362
Acute hepatic failure 23.73 14.53 20 8225 15657 50581222
Haemoptysis 22.21 14.53 24 8221 25549 50571330
Prothrombin time prolonged 21.60 14.53 15 8230 8823 50588056
Neonatal anuria 21.13 14.53 4 8241 42 50596837
Necrotising enterocolitis neonatal 21.13 14.53 5 8240 161 50596718
Respiratory failure 20.91 14.53 46 8199 91135 50505744
Vitamin K deficiency 20.87 14.53 6 8239 417 50596462
Activated partial thromboplastin time prolonged 20.85 14.53 13 8232 6389 50590490
Blood alkaline phosphatase increased 20.75 14.53 28 8217 37498 50559381
Acute respiratory distress syndrome 20.46 14.53 21 8224 21078 50575801
Acute kidney injury 20.19 14.53 82 8163 227976 50368903
Drug intolerance 19.05 14.53 6 8239 219098 50377781
Terminal ileitis 18.70 14.53 6 8239 605 50596274
Rheumatoid arthritis 18.61 14.53 5 8240 202545 50394334
HER2 positive breast cancer 18.01 14.53 5 8240 306 50596573
Gamma-glutamyltransferase increased 17.76 14.53 23 8222 29600 50567279
Hypokalaemia 17.53 14.53 42 8203 87950 50508929
Cytokine release syndrome 17.32 14.53 13 8232 8621 50588258
Pelvic fluid collection 17.24 14.53 6 8239 777 50596102
Oligohydramnios 17.04 14.53 11 8234 5739 50591140
Pulmonary pain 16.82 14.53 8 8237 2307 50594572
Pulmonary function test decreased 16.68 14.53 9 8236 3379 50593500
Aspartate aminotransferase increased 16.37 14.53 38 8207 77960 50518919
Pain 16.17 14.53 45 8200 578858 50018021
Hepatic encephalopathy 16.06 14.53 13 8232 9623 50587256
Jugular vein thrombosis 15.66 14.53 8 8237 2688 50594191
Foetal growth restriction 15.62 14.53 11 8234 6616 50590263
Suspected transmission of an infectious agent via product 14.55 14.53 4 8241 236 50596643

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Appendicolith 245.13 15.04 76 9545 3404 29561502
Infective pulmonary exacerbation of cystic fibrosis 187.27 15.04 72 9549 6164 29558742
Ascites 183.79 15.04 126 9495 36493 29528413
Appendicitis 179.81 15.04 77 9544 8702 29556204
Cardiogenic shock 138.31 15.04 83 9538 19107 29545799
Multiple organ dysfunction syndrome 129.22 15.04 129 9492 62987 29501919
Stress 114.98 15.04 77 9544 21413 29543493
Abdominal distension 105.46 15.04 100 9521 45811 29519095
Toxic epidermal necrolysis 67.14 15.04 52 9569 18101 29546805
Sepsis 67.09 15.04 145 9476 142537 29422369
Hyponatraemia 66.24 15.04 95 9526 67538 29497368
International normalised ratio increased 64.88 15.04 76 9545 44296 29520610
Abdominal pain 60.71 15.04 135 9486 135222 29429684
Cystic fibrosis 43.95 15.04 17 9604 1475 29563431
Ventricular fibrillation 43.15 15.04 38 9583 15795 29549111
Hepatic failure 42.78 15.04 52 9569 31460 29533446
Hyper IgE syndrome 39.76 15.04 8 9613 55 29564851
General physical health deterioration 37.79 15.04 95 9526 102762 29462144
Constipation 37.40 15.04 101 9520 114059 29450847
Vomiting 31.93 15.04 145 9476 212115 29352791
Epileptic encephalopathy 24.20 15.04 6 9615 115 29564791
Hyperbilirubinaemia 24.19 15.04 27 9594 14907 29549999
Hepatic encephalopathy 23.62 15.04 25 9596 13010 29551896
Acute hepatic failure 23.59 15.04 24 9597 11928 29552978
Hyphaema 23.52 15.04 8 9613 480 29564426
Cystic fibrosis related diabetes 23.17 15.04 6 9615 138 29564768
Death 22.30 15.04 49 9572 342035 29222871
Activated partial thromboplastin time prolonged 21.93 15.04 19 9602 7723 29557183
Toxicity to various agents 20.40 15.04 16 9605 173645 29391261
Cortical visual impairment 20.21 15.04 4 9617 25 29564881
Coagulation time prolonged 19.56 15.04 9 9612 1201 29563705
Coagulopathy 18.74 15.04 26 9595 17881 29547025
Prothrombin time prolonged 17.91 15.04 18 9603 8814 29556092
Blood bilirubin increased 17.66 15.04 36 9585 33857 29531049
Myocardial infarction 17.48 15.04 7 9614 110289 29454617
Iatrogenic infection 17.12 15.04 4 9617 59 29564847
Drug ineffective 16.99 15.04 61 9560 363109 29201797
Skin candida 16.67 15.04 6 9615 426 29564480
Respiratory failure 15.78 15.04 68 9553 97063 29467843
Genital herpes 15.14 15.04 6 9615 555 29564351
Dizziness 15.12 15.04 24 9597 189660 29375246

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 344.46 14.10 124 15810 11672 64471126
Appendicolith 265.90 14.10 76 15858 3393 64479405
Ascites 222 14.10 156 15778 61845 64420953
Multiple organ dysfunction syndrome 177.39 14.10 168 15766 101245 64381553
Appendicitis 167.86 14.10 77 15857 13492 64469306
Cardiogenic shock 138.36 14.10 91 15843 32336 64450462
International normalised ratio increased 117.57 14.10 120 15814 79047 64403751
Sepsis 103.92 14.10 196 15738 230145 64252653
Abdominal distension 92.13 14.10 116 15818 95878 64386920
Cystic fibrosis 74.29 14.10 29 15905 3405 64479393
Stress 72.64 14.10 82 15852 60452 64422346
Hepatic failure 61.34 14.10 72 15862 55322 64427476
Toxic epidermal necrolysis 54.51 14.10 56 15878 37110 64445688
Coagulopathy 54.03 14.10 52 15882 31868 64450930
Ventricular fibrillation 44.46 14.10 41 15893 23819 64458979
Respiratory failure 41.75 14.10 110 15824 161073 64321725
Hyponatraemia 40.23 14.10 103 15831 148236 64334562
Activated partial thromboplastin time prolonged 38.39 14.10 29 15905 12802 64469996
Abdominal pain 37.80 14.10 165 15769 312210 64170588
Hepatic encephalopathy 36.94 14.10 35 15899 21031 64461767
Acute hepatic failure 35.87 14.10 38 15896 26074 64456724
Haemoptysis 34.46 14.10 51 15883 48997 64433801
Renal vascular thrombosis 34.38 14.10 7 15927 70 64482728
Prothrombin time prolonged 33.18 14.10 29 15905 15712 64467086
Constipation 33.14 14.10 128 15806 229209 64253589
Hyperbilirubinaemia 33.00 14.10 33 15901 21172 64461626
Factor V inhibition 32.72 14.10 9 15925 348 64482450
Drug intolerance 32.69 14.10 4 15930 187988 64294810
Thrombocytopenia 32.41 14.10 125 15809 223676 64259122
Cytokine release syndrome 31.65 14.10 32 15902 20797 64462001
General physical health deterioration 31.10 14.10 116 15818 204309 64278489
Pain 30.07 14.10 57 15877 553454 63929344
Osteochondritis 27.92 14.10 5 15929 23 64482775
Toxicity to various agents 27.02 14.10 30 15904 363483 64119315
Hyper IgE syndrome 25.57 14.10 8 15926 487 64482311
Cholestasis 25.06 14.10 42 15892 44830 64437968
Transverse sinus thrombosis 23.80 14.10 8 15926 612 64482186
Cystic fibrosis related diabetes 23.44 14.10 6 15928 175 64482623
Hyphaema 23.37 14.10 8 15926 647 64482151
Drug ineffective 23.18 14.10 118 15816 840129 63642669
Coagulation time prolonged 22.89 14.10 11 15923 2135 64480663
Blood bilirubin increased 22.26 14.10 46 15888 57507 64425291
Cortical visual impairment 21.74 14.10 4 15930 22 64482776
Dizziness 21.04 14.10 47 15887 430116 64052682
Acute kidney injury 20.69 14.10 185 15749 449055 64033743
Sputum increased 20.01 14.10 12 15922 3623 64479175
Distal intestinal obstruction syndrome 19.71 14.10 7 15927 631 64482167
Subdural haematoma 19.46 14.10 29 15905 28025 64454773
Intestinal dilatation 19.40 14.10 10 15924 2254 64480544
Fall 19.21 14.10 47 15887 416779 64066019
Haematemesis 18.69 14.10 38 15896 46961 64435837
Epileptic encephalopathy 18.59 14.10 6 15928 404 64482394
Iatrogenic infection 18.21 14.10 4 15930 59 64482739
Pulmonary function test decreased 18.00 14.10 14 15920 6447 64476351
Restrictive cardiomyopathy 17.59 14.10 7 15927 864 64481934
Contraindicated product administered 17.11 14.10 3 15931 107826 64374972
Septic shock 16.99 14.10 61 15873 105376 64377422
Jugular vein thrombosis 16.93 14.10 11 15923 3820 64478978
Superior sagittal sinus thrombosis 16.82 14.10 7 15927 969 64481829
HER2 positive breast cancer 16.71 14.10 5 15929 262 64482536
Transaminases increased 16.49 14.10 35 15899 44559 64438239
Vomiting 16.46 14.10 208 15726 550909 63931889
Disseminated intravascular coagulation 16.38 14.10 29 15905 32319 64450479
Tumour lysis syndrome 16.29 14.10 22 15912 19418 64463380
Blood alkaline phosphatase increased 16.20 14.10 40 15894 56239 64426559
Vitamin K deficiency 15.63 14.10 6 15928 673 64482125
Jaundice 15.60 14.10 36 15898 48476 64434322
Neutropenic colitis 15.15 14.10 11 15923 4570 64478228
Pancreatitis chronic 15.13 14.10 10 15924 3576 64479222
Drug reaction with eosinophilia and systemic symptoms 15.04 14.10 38 15896 54179 64428619
Acute respiratory distress syndrome 14.91 14.10 31 15903 38904 64443894
Bacteraemia 14.77 14.10 25 15909 26886 64455912
Hepatorenal syndrome 14.73 14.10 10 15924 3736 64479062
Heparin-induced thrombocytopenia 14.69 14.10 14 15920 8465 64474333
Joint swelling 14.68 14.10 19 15915 215363 64267435
Lactobacillus test positive 14.64 14.10 3 15931 31 64482767
C-reactive protein decreased 14.35 14.10 8 15926 2108 64480690
Medical device site haemorrhage 14.15 14.10 4 15930 171 64482627
Gait disturbance 14.15 14.10 13 15921 172142 64310656

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B02BA01 BLOOD AND BLOOD FORMING ORGANS
ANTIHEMORRHAGICS
VITAMIN K AND OTHER HEMOSTATICS
Vitamin K
FDA CS M0022806 Vitamin K
MeSH PA D000933 Antifibrinolytic Agents
MeSH PA D003029 Coagulants
MeSH PA D006401 Hematologic Agents
MeSH PA D006490 Hemostatics
MeSH PA D018977 Micronutrients
MeSH PA D014815 Vitamins
FDA PE N0000175965 Increased Prothrombin Activity
FDA EPC N0000175966 Warfarin Reversal Agent
FDA PE N0000175982 Reversed Anticoagulation Activity
FDA EPC N0000180191 Vitamin K
CHEBI has role CHEBI:23357 cofactor
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:24020 fat-soluble vitamins
CHEBI has role CHEBI:75771 Mus musculus metabolites

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypocalcemia indication 5291005
Osteoporosis indication 64859006 DOID:11476
Factor II deficiency indication 73975000
Postmenopausal osteoporosis indication 102447009
Prevention of Neonatal Hemorrhagic Disease indication
Antibiotic-Induced Hypoprothrombinemia indication
Neonatal Hemorrhagic Disease indication
Vitamin K Deficiency Induced Hypoprothrombinemia indication
Anticoagulant-Induced Prothrombin Deficiency indication
Obstruction of bile duct off-label use 30144000
Abetalipoproteinemia off-label use 190787008 DOID:1386
Constipation contraindication 14760008 DOID:2089
Hyperphosphatemia contraindication 20165001 DOID:0050459
Hypervitaminosis D contraindication 27712000 DOID:9971
Sarcoidosis contraindication 31541009 DOID:11335
Dehydration contraindication 34095006
Vitamin E deficiency contraindication 54137008
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Diabetes mellitus contraindication 73211009 DOID:9351
Kidney disease contraindication 90708001 DOID:557
Kidney stone contraindication 95570007
Anemia due to enzyme deficiency contraindication 111577008
Neoplasm of endometrium contraindication 123844007 DOID:1380
Neoplasm of prostate contraindication 126906006 DOID:10283
Osteolysis contraindication 203522001
Arteriosclerosis obliterans contraindication 361133006 DOID:5160
Malignant tumor of cervix contraindication 363354003 DOID:4362
Central nervous system depression contraindication 418072004
Carcinoma of female breast contraindication 447782002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG/ML PHYTONADIONE CIPLA A214596 April 22, 2022 RX INJECTABLE INJECTION Oct. 30, 2022 COMPETITIVE GENERIC THERAPY
1MG/0.5ML PHYTONADIONE CIPLA A214596 April 22, 2022 RX INJECTABLE INJECTION Oct. 30, 2022 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Alpha-synuclein Transporter IC50 4.82 CHEMBL

External reference:

IDSource
4017772 VUID
N0000146136 NUI
D00148 KEGG_DRUG
4017772 VANDF
4018981 VANDF
4021719 VANDF
4021911 VANDF
C0031862 UMLSCUI
CHEBI:18067 CHEBI
PQN PDB_CHEM_ID
CHEMBL1550 ChEMBL_ID
CHEMBL1201519 ChEMBL_ID
DB01022 DRUGBANK_ID
5284607 PUBCHEM_CID
11258 RXNORM
1433 MMSL
15677 MMSL
199215 MMSL
42273 MMSL
5298 MMSL
d03135 MMSL
001038 NDDF
001042 NDDF
63136007 SNOMEDCT_US
65183007 SNOMEDCT_US
66656000 SNOMEDCT_US
74226000 SNOMEDCT_US
D010837 MESH_DESCRIPTOR_UI
D014812 MESH_DESCRIPTOR_UI
177 INN_ID
A034SE7857 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Mephyton HUMAN PRESCRIPTION DRUG LABEL 1 0187-1704 TABLET 5 mg ORAL NDA 22 sections
Mephyton HUMAN PRESCRIPTION DRUG LABEL 1 0187-1704 TABLET 5 mg ORAL NDA 22 sections
PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9935 INJECTION, EMULSION 1 mg PARENTERAL ANDA 16 sections
PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9969 INJECTION, EMULSION 10 mg INTRAMUSCULAR ANDA 12 sections
Vitamin K1 HUMAN PRESCRIPTION DRUG LABEL 1 0409-9157 INJECTION, EMULSION 2 mg INTRAMUSCULAR ANDA 18 sections
Vitamin K1 HUMAN PRESCRIPTION DRUG LABEL 1 0409-9158 INJECTION, EMULSION 10 mg INTRAMUSCULAR ANDA 18 sections
Phytonadione HUMAN PRESCRIPTION DRUG LABEL 1 0904-6882 TABLET 5 mg ORAL ANDA 28 sections
Phytonadione HUMAN PRESCRIPTION DRUG LABEL 1 0904-6882 TABLET 5 mg ORAL ANDA 28 sections
Phytonadione HUMAN PRESCRIPTION DRUG LABEL 1 16714-973 TABLET 5 mg ORAL ANDA 21 sections
Phytonadione HUMAN PRESCRIPTION DRUG LABEL 1 16714-973 TABLET 5 mg ORAL ANDA 21 sections
MEPHYTON HUMAN PRESCRIPTION DRUG LABEL 1 21695-168 TABLET 5 mg ORAL NDA 21 sections
PHYTONADIONE PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 43598-405 INJECTION, EMULSION 10 mg INTRAMUSCULAR ANDA 19 sections
Mephyton HUMAN PRESCRIPTION DRUG LABEL 1 50090-1753 TABLET 5 mg ORAL NDA 20 sections
Vitamin K1 HUMAN PRESCRIPTION DRUG LABEL 1 50090-4521 INJECTION, EMULSION 10 mg INTRAMUSCULAR ANDA 19 sections
Vitamin K1 HUMAN PRESCRIPTION DRUG LABEL 1 50090-4523 INJECTION, EMULSION 2 mg INTRAMUSCULAR ANDA 19 sections
Phytonadione HUMAN PRESCRIPTION DRUG LABEL 1 50268-661 TABLET 5 mg ORAL NDA authorized generic 20 sections
VITAMIN K1 - PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1536 INJECTION, EMULSION 10 mg INTRAMUSCULAR ANDA 13 sections
VITAMIN K1 PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1537 INJECTION, EMULSION 2 mg INTRAMUSCULAR ANDA 13 sections
PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 52584-043 INJECTION, EMULSION 1 mg PARENTERAL ANDA 13 sections
PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 52584-046 INJECTION, EMULSION 1 mg PARENTERAL ANDA 16 sections
Phytonadione HUMAN PRESCRIPTION DRUG LABEL 1 52584-240 INJECTION, EMULSION 1 mg PARENTERAL ANDA 13 sections
PHYTONADIONE HUMAN PRESCRIPTION DRUG LABEL 1 52584-405 INJECTION, EMULSION 10 mg INTRAMUSCULAR ANDA 12 sections
PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION HUMAN PRESCRIPTION DRUG LABEL 13 54643-5646 INJECTION, SOLUTION 0.20 mg INTRAVENOUS NDA 19 sections
Adult Infuvite Multiple Vitamins for Infusion HUMAN PRESCRIPTION DRUG LABEL 13 54643-5649 INJECTION, SOLUTION 150 ug INTRAVENOUS NDA 17 sections
Adult Infuvite Multiple Vitamins for Infusion HUMAN PRESCRIPTION DRUG LABEL 13 54643-5649 INJECTION, SOLUTION 150 ug INTRAVENOUS NDA 17 sections
Infuvite Adult Multiple Vitamins HUMAN PRESCRIPTION DRUG LABEL 13 54643-5650 INJECTION, SOLUTION 150 ug INTRAVENOUS NDA 20 sections
Adult Infuvite Multiple Vitamins HUMAN PRESCRIPTION DRUG LABEL 13 54643-7862 INJECTION, SOLUTION 150 ug INTRAVENOUS NDA 20 sections
Adult Infuvite Multiple Vitamins HUMAN PRESCRIPTION DRUG LABEL 13 54643-7874 INJECTION, SOLUTION 150 ug INTRAVENOUS NDA 20 sections
Pediatric Infuvite Multiple Vitamins HUMAN PRESCRIPTION DRUG LABEL 13 54643-7886 INJECTION, SOLUTION 0.20 mg INTRAVENOUS NDA 19 sections
Adult Infuvite Multiple Vitamins HUMAN PRESCRIPTION DRUG LABEL 13 54643-9007 INJECTION, SOLUTION 150 ug INTRAVENOUS NDA 20 sections