nitrofurantoin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
NO2 - derivatives 1949 67-20-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nitrofurantoin sodium
  • nitrofurantoin
  • furadantin
  • furadantoin
  • nitrofurantoin, macrocrystalline
  • nitrofurantoin monohydrate
A urinary anti-infective agent effective against most gram-positive and gram-negative organisms. Although sulfonamides and antibiotics are usually the agents of choice for urinary tract infections, nitrofurantoin is widely used for prophylaxis and long-term suppression.
  • Molecular weight: 238.16
  • Formula: C8H6N4O5
  • CLOGP: -0.47
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 1
  • TPSA: 120.73
  • ALOGS: -2.76
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.19 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 47 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 24 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 87 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.57 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.17 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.97 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 6, 1953 FDA

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
Urinary tract infection 563.00 10.66 779 38198 239124 53070965
Drug hypersensitivity 354.12 10.66 667 38310 264575 53045514
Autoimmune hepatitis 208.99 10.66 108 38869 8210 53301879
Cystitis 180.12 10.66 196 38781 46792 53263297
Rheumatoid arthritis 123.89 10.66 38 38939 314493 52995596
Drug ineffective 107.89 10.66 278 38699 816967 52493122
Jaundice 96.69 10.66 115 38862 30198 53279891
Pulmonary toxicity 86.15 10.66 52 38925 5339 53304750
Contraindicated product administered 73.65 10.66 7 38970 135622 53174467
Drug-induced liver injury 69.71 10.66 96 38881 29137 53280952
Infusion related reaction 68.65 10.66 15 38962 155942 53154147
Pulmonary fibrosis 60.18 10.66 81 38896 24054 53286035
Injury 58.92 10.66 121 38856 50850 53259239
Therapeutic product effect decreased 51.55 10.66 14 38963 125641 53184448
Drug intolerance 51.06 10.66 45 38932 205448 53104641
Lip swelling 49.94 10.66 79 38898 27122 53282967
Off label use 48.25 10.66 180 38797 472032 52838057
Interstitial lung disease 44.49 10.66 118 38859 58504 53251585
Systemic lupus erythematosus 42.80 10.66 19 38958 125395 53184694
Glossodynia 39.61 10.66 12 38965 100279 53209810
Systemic inflammatory response syndrome 37.62 10.66 32 38945 5628 53304461
Treatment failure 37.16 10.66 24 38953 128379 53181710
Arthropathy 36.31 10.66 30 38947 141423 53168666
Kidney infection 34.48 10.66 55 38922 19012 53291077
Oesophageal spasm 34.04 10.66 22 38955 2546 53307543
Hepatic fibrosis 33.75 10.66 24 38953 3249 53306840
Heart sounds 32.95 10.66 13 38964 522 53309567
Wound 32.63 10.66 13 38964 91544 53218545
Malaise 31.03 10.66 398 38579 357219 52952870
Oesophageal pain 30.77 10.66 22 38955 3004 53307085
Emotional distress 29.71 10.66 70 38907 32247 53277842
Amblyopia 29.38 10.66 10 38967 262 53309827
Pericarditis 28.72 10.66 6 38971 64400 53245689
Pollakiuria 28.28 10.66 60 38917 25779 53284310
Cardiac murmur 28.21 10.66 39 38938 11874 53298215
Dysuria 28.04 10.66 66 38911 30387 53279702
Prolonged expiration 27.56 10.66 12 38965 620 53309469
Eosinophilia 27.47 10.66 53 38924 21282 53288807
Febrile neutropenia 27.24 10.66 22 38955 104914 53205175
Multiple sclerosis relapse 26.94 10.66 83 38894 44770 53265319
Joint swelling 26.90 10.66 85 38892 234553 53075536
Costovertebral angle tenderness 26.56 10.66 7 38970 73 53310016
Swollen tongue 26.09 10.66 65 38912 31015 53279074
Bladder disorder 25.26 10.66 30 38947 7858 53302231
Hepatic cirrhosis 24.72 10.66 46 38931 17976 53292113
Hypersensitivity pneumonitis 24.57 10.66 18 38959 2552 53307537
Death 24.34 10.66 157 38820 357075 52953014
Change of bowel habit 24.29 10.66 16 38961 1912 53308177
Uterine perforation 23.40 10.66 28 38949 7391 53302698
Liver function test abnormal 22.68 10.66 82 38895 47989 53262100
Pyelonephritis 22.61 10.66 42 38935 16395 53293694
Urosepsis 22.29 10.66 42 38935 16568 53293521
Multiple sclerosis 21.97 10.66 56 38921 27097 53282992
Neurogenic bladder 21.81 10.66 18 38959 3038 53307051
Escherichia urinary tract infection 21.27 10.66 33 38944 11140 53298949
Atrioventricular block first degree 21.17 10.66 25 38952 6510 53303579
Nephrolithiasis 21.14 10.66 67 38910 36680 53273409
Alopecia 21.01 10.66 94 38883 234489 53075600
Chromaturia 21.00 10.66 40 38937 15910 53294179
Neutropenia 20.92 10.66 54 38923 159131 53150958
Drug abuse 20.71 10.66 11 38966 65515 53244574
Rales 20.63 10.66 32 38945 10800 53299289
Liver transplant 20.59 10.66 16 38961 2478 53307611
Cystitis interstitial 20.47 10.66 13 38964 1460 53308629
Cholecystitis chronic 19.93 10.66 31 38946 10487 53299602
Ureteric obstruction 19.84 10.66 14 38963 1872 53308217
Liver injury 19.37 10.66 47 38930 22056 53288033
Urine odour abnormal 19.28 10.66 22 38955 5524 53304565
Intentional overdose 18.84 10.66 13 38964 67192 53242897
Acute hepatic failure 18.50 10.66 39 38938 16681 53293408
Anhedonia 18.20 10.66 30 38947 10657 53299432
Chronic hepatitis 18.15 10.66 10 38967 864 53309225
Drug reaction with eosinophilia and systemic symptoms 18.14 10.66 59 38918 32741 53277348
Hepatic enzyme increased 18.01 10.66 41 38936 126154 53183935
Overdose 17.94 10.66 32 38945 107704 53202385
Foetal heart rate decreased 17.67 10.66 6 38971 156 53309933
Jaundice cholestatic 17.64 10.66 21 38956 5513 53304576
Urine analysis abnormal 17.62 10.66 19 38958 4481 53305608
Completed suicide 17.31 10.66 48 38929 138153 53171936
Myelocyte percentage increased 17.29 10.66 6 38971 167 53309922
Pseudophaeochromocytoma 17.18 10.66 5 38972 77 53310012
Rectal polyp 17.10 10.66 10 38967 968 53309121
Flank pain 17.08 10.66 34 38943 13962 53296127
Fracture displacement 17.04 10.66 11 38966 1270 53308819
Hallucination 16.87 10.66 81 38896 53757 53256332
Acute febrile neutrophilic dermatosis 16.48 10.66 15 38962 2886 53307203
Therapeutic product effect incomplete 16.45 10.66 26 38951 91758 53218331
Colour blindness acquired 16.40 10.66 5 38972 91 53309998
Product use issue 16.38 10.66 50 38927 139534 53170555
Breath sounds abnormal 16.08 10.66 25 38952 8452 53301637
Respiration abnormal 16.07 10.66 20 38957 5498 53304591
Hiccups 16.03 10.66 12 38965 1758 53308331
Bladder irritation 15.88 10.66 6 38971 214 53309875
Urine oxalate increased 15.85 10.66 6 38971 215 53309874
Band neutrophil percentage increased 15.72 10.66 6 38971 220 53309869
Toxicity to various agents 15.71 10.66 95 38882 219503 53090586
Therapy interrupted 15.63 10.66 40 38937 19396 53290693
Umbilical cord around neck 15.60 10.66 6 38971 225 53309864
Bladder operation 15.49 10.66 9 38968 861 53309228
Traumatic lung injury 15.32 10.66 11 38966 1512 53308577
Upper respiratory tract congestion 15.30 10.66 12 38965 1883 53308206
Hepatitis 15.30 10.66 57 38920 33837 53276252
Lymphoedema 14.98 10.66 26 38951 9627 53300462
Subacute cutaneous lupus erythematosus 14.95 10.66 13 38964 2355 53307734
Oesophageal cancer metastatic 14.88 10.66 5 38972 126 53309963
Wheezing 14.87 10.66 90 38887 65185 53244904
Eosinophilic pleural effusion 14.82 10.66 4 38973 46 53310043
Blood urine present 14.71 10.66 31 38946 13254 53296835
Urine leukocyte esterase positive 14.41 10.66 14 38963 2922 53307167
Retinal depigmentation 14.39 10.66 6 38971 278 53309811
Sensitisation 14.18 10.66 10 38967 1335 53308754
Abdominal discomfort 14.10 10.66 99 38878 220963 53089126
Lower urinary tract symptoms 14.10 10.66 4 38973 56 53310033
Anaemia 13.96 10.66 132 38845 276586 53033503
Hepatic necrosis 13.88 10.66 19 38958 5731 53304358
Hepatitis acute 13.82 10.66 24 38953 8892 53301197
Appetite disorder 13.41 10.66 20 38957 6523 53303566
Depressive symptom 13.17 10.66 14 38963 3250 53306839
Micturition urgency 13.13 10.66 23 38954 8579 53301510
Retroperitoneal fibrosis 13.12 10.66 6 38971 348 53309741
Band neutrophil count increased 12.93 10.66 6 38971 360 53309729
Arthralgia 12.89 10.66 235 38742 439548 52870541
Walking aid user 12.87 10.66 19 38958 6139 53303950
Muscle injury 12.81 10.66 3 38974 29763 53280326
Intestinal haemorrhage 12.56 10.66 14 38963 3426 53306663
Specific gravity urine decreased 12.53 10.66 7 38970 621 53309468
Myelocyte count increased 12.53 10.66 6 38971 387 53309702
Urinary tract infection bacterial 12.51 10.66 16 38961 4518 53305571
Cholelithiasis 12.38 10.66 61 38916 40903 53269186
Clostridium difficile colitis 12.26 10.66 37 38940 19728 53290361
Cardio-respiratory arrest 12.17 10.66 15 38962 58743 53251346
Pneumonia viral 12.16 10.66 20 38957 7092 53302997
Folliculitis 12.15 10.66 4 38973 31705 53278384
Urinary retention 12.13 10.66 47 38930 28419 53281670
Culture urine positive 12.12 10.66 14 38963 3561 53306528
Hydronephrosis 12.03 10.66 23 38954 9173 53300916
Chronic kidney disease 12.00 10.66 63 38914 43307 53266782
Swelling 11.98 10.66 86 38891 191019 53119070
Rash macular 11.98 10.66 38 38939 20809 53289280
Lichen sclerosus 11.86 10.66 8 38969 994 53309095
Klebsiella test positive 11.64 10.66 8 38969 1025 53309064
Product contamination microbial 11.58 10.66 5 38972 253 53309836
Knee arthroplasty 11.58 10.66 5 38972 33564 53276525
Irritable bowel syndrome 11.50 10.66 9 38968 43623 53266466
Meconium in amniotic fluid 11.47 10.66 5 38972 259 53309830
Adverse event 11.43 10.66 8 38969 41053 53269036
Vulvovaginal swelling 11.39 10.66 6 38971 474 53309615
Haematuria 11.39 10.66 46 38931 28343 53281746
Discomfort 11.34 10.66 34 38943 95438 53214651
Abdominal rigidity 11.30 10.66 10 38967 1854 53308235
Musculoskeletal stiffness 11.29 10.66 49 38928 123319 53186770
Monocyte percentage increased 11.27 10.66 8 38969 1079 53309010
Gallbladder disorder 11.26 10.66 34 38943 18131 53291958
Pulmonary arterial hypertension 11.16 10.66 3 38974 27119 53282970
Leukocyturia 11.14 10.66 8 38969 1099 53308990
Therapeutic response decreased 11.11 10.66 11 38966 47558 53262531
Psoriasis 11.09 10.66 30 38947 87059 53223030
White blood cells urine positive 10.94 10.66 15 38962 4530 53305559
Traumatic liver injury 10.94 10.66 5 38972 290 53309799
Rash 10.80 10.66 413 38564 445778 52864311
Fluid intake reduced 10.79 10.66 13 38964 3456 53306633

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
Urinary tract infection 187.26 17.43 138 5820 79933 32427635
Exposure during pregnancy 72.83 17.43 35 5923 9194 32498374
Urosepsis 40.69 17.43 26 5932 11864 32495704
Oxidative stress 36.84 17.43 7 5951 66 32507502
Pulmonary fibrosis 36.69 17.43 28 5930 16946 32490622
Protein total abnormal 30.66 17.43 8 5950 343 32507225
Pulmonary valve stenosis 30.22 17.43 8 5950 363 32507205
Prostatitis 29.82 17.43 16 5942 5284 32502284
Skin depigmentation 29.41 17.43 8 5950 403 32507165
Cardiac murmur 27.81 17.43 17 5941 7174 32500394
Foetal exposure during pregnancy 27.78 17.43 36 5922 41265 32466303
Hair colour changes 25.14 17.43 10 5948 1667 32505901
Haematuria 24.81 17.43 37 5921 48324 32459244
Tendonitis 24.79 17.43 17 5941 8718 32498850
Urinary retention 23.82 17.43 31 5927 35666 32471902
Culture urine positive 23.62 17.43 9 5949 1338 32506230
Tooth injury 23.45 17.43 8 5950 867 32506701
Porphyria non-acute 23.28 17.43 7 5951 505 32507063
Atrial septal defect 23.14 17.43 15 5943 7010 32500558
Breast inflammation 22.79 17.43 4 5954 23 32507545
Melanocytic naevus 22.78 17.43 10 5948 2131 32505437
Plantar fasciitis 22.33 17.43 8 5950 1001 32506567
Multiple sclerosis 21.98 17.43 15 5943 7629 32499939
Patent ductus arteriosus 21.57 17.43 11 5947 3274 32504294
Clonic convulsion 21.54 17.43 7 5951 652 32506916
Blood chromogranin A increased 19.50 17.43 5 5953 200 32507368
Eye swelling 18.96 17.43 15 5943 9557 32498011
Therapy interrupted 18.95 17.43 14 5944 8064 32499504
Multiple congenital abnormalities 18.78 17.43 6 5952 530 32507038
Skin exfoliation 18.61 17.43 23 5935 25134 32482434
Carcinoid crisis 18.39 17.43 5 5953 251 32507317
Defaecation urgency 18.17 17.43 8 5950 1717 32505851
Gastric ulcer 17.80 17.43 18 5940 15791 32491777
Bone neoplasm 17.63 17.43 5 5953 294 32507274

Pharmacologic Action:

SourceCodeDescription
ATC J01XE01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Nitrofuran derivatives
ATC J01XE51 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Nitrofuran derivatives
FDA CS M0014892 Nitrofurans
FDA EPC N0000175494 Nitrofuran Antibacterial
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000892 Anti-Infective Agents, Urinary
CHEBI has role CHEBI:35441 anti-infective drugs
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:50908 agente hepatotoxico

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Klebsiella cystitis indication 60867007
Escherichia coli urinary tract infection indication 301011002
Staphylococcus Saprophyticus Urinary Tract Infection indication
Enterobacter Cystitis indication
Enterococcus Urinary Tract Infection indication
Staphylococcus Aureus Urinary Tract Infection indication
Prevention of Bacterial Urinary Tract Infection off-label use
Anuria contraindication 2472002 DOID:2983
Acute hepatitis contraindication 37871000
Vitamin B deficiency contraindication 47903000
Fibrosis of lung contraindication 51615001 DOID:3770
Obstructive hyperbilirubinemia contraindication 59848001
Interstitial pneumonia contraindication 64667001
Optic neuritis contraindication 66760008 DOID:1210
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic hepatitis contraindication 76783007 DOID:2237
Oliguria contraindication 83128009
Cholestatic hepatitis contraindication 95556007
Anemia due to enzyme deficiency contraindication 111577008
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Cobalamin deficiency contraindication 190634004
Impaired renal function disorder contraindication 197663003
Drug-induced hepatitis contraindication 235876009
Peripheral nerve disease contraindication 302226006
Pseudomembranous enterocolitis contraindication 397683000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.28 acidic
pKa2 0.0 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucose-6-phosphate 1-dehydrogenase Enzyme WOMBAT-PK
CDGSH iron-sulfur domain-containing protein 1 Unclassified Ki 6.09 CHEMBL

External reference:

IDSource
4018849 VUID
N0000147151 NUI
D00439 KEGG_DRUG
54-87-5 SECONDARY_CAS_RN
4018848 VANDF
4018849 VANDF
C0028156 UMLSCUI
CHEBI:71415 CHEBI
U6Z PDB_CHEM_ID
CHEMBL572 ChEMBL_ID
DB00698 DRUGBANK_ID
CHEMBL1201000 ChEMBL_ID
D009582 MESH_DESCRIPTOR_UI
6604200 PUBCHEM_CID
488 INN_ID
10917 IUPHAR_LIGAND_ID
927AH8112L UNII
221129 RXNORM
181427 MMSL
2320 MMSL
404 MMSL
5179 MMSL
5180 MMSL
5181 MMSL
d00112 MMSL
002852 NDDF
002853 NDDF
002854 NDDF
373543005 SNOMEDCT_US
37978007 SNOMEDCT_US
426476003 SNOMEDCT_US
427332002 SNOMEDCT_US
85343003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nitrofurantoin Macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 0115-1643 CAPSULE 50 mg ORAL ANDA 25 sections
Nitrofurantoin Macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 0115-1645 CAPSULE 100 mg ORAL ANDA 25 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 1 0115-2023 CAPSULE 50 mg ORAL ANDA 25 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 1 0115-2024 CAPSULE 100 mg ORAL ANDA 25 sections
Nitrofurantoin (monohydrate/macrocrystals) HUMAN PRESCRIPTION DRUG LABEL 2 0185-0122 CAPSULE 25 mg ORAL ANDA 25 sections
Nitrofurantoin (monohydrate/macrocrystals) HUMAN PRESCRIPTION DRUG LABEL 2 0185-0122 CAPSULE 75 mg ORAL ANDA 25 sections
Nitrofurantoin Macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 0440-1866 CAPSULE 100 mg ORAL ANDA 26 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 1 0472-1992 SUSPENSION 25 mg ORAL ANDA 19 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-3684 CAPSULE 25 mg ORAL ANDA 21 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-3685 CAPSULE 50 mg ORAL ANDA 21 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 1 0591-3686 CAPSULE 100 mg ORAL ANDA 21 sections
nitrofurantoin macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 0904-7025 CAPSULE 100 mg ORAL ANDA 13 sections
nitrofurantoin macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 0904-7026 CAPSULE 50 mg ORAL ANDA 13 sections
nitrofurantoin macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 0904-7136 CAPSULE 100 mg ORAL NDA 25 sections
Nitrofurantoin Monohydrate/ Macrocrystalline HUMAN PRESCRIPTION DRUG LABEL 2 10544-086 CAPSULE 25 mg ORAL NDA 28 sections
Nitrofurantoin Monohydrate/ Macrocrystalline HUMAN PRESCRIPTION DRUG LABEL 2 10544-086 CAPSULE 75 mg ORAL NDA 28 sections
Nitrofurantoin Macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 10544-601 CAPSULE 100 mg ORAL ANDA 24 sections
Nitrofurantion Macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 12634-415 CAPSULE 100 mg ORAL NDA 24 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 2 13811-719 CAPSULE 75 mg ORAL ANDA 25 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 2 13811-719 CAPSULE 25 mg ORAL ANDA 25 sections
Nitrofurantoin Human Prescription Drug Label 1 16571-740 SUSPENSION 25 mg ORAL NDA AUTHORIZED GENERIC 19 sections
NITROFURANTOIN MACROCRYSTALS HUMAN PRESCRIPTION DRUG LABEL 1 16590-380 CAPSULE 100 mg ORAL ANDA 24 sections
Nitrofurantoin (monohydrate/macrocrystals) HUMAN PRESCRIPTION DRUG LABEL 2 16714-439 CAPSULE 25 mg ORAL ANDA 23 sections
Nitrofurantoin (monohydrate/macrocrystals) HUMAN PRESCRIPTION DRUG LABEL 2 16714-439 CAPSULE 75 mg ORAL ANDA 23 sections
Nitrofurantoin (monohydrate/macrocrystals) HUMAN PRESCRIPTION DRUG LABEL 2 21695-300 CAPSULE 25 mg ORAL ANDA 27 sections
Nitrofurantoin (monohydrate/macrocrystals) HUMAN PRESCRIPTION DRUG LABEL 2 21695-300 CAPSULE 75 mg ORAL ANDA 27 sections
Nitrofurantoin Monohydrate/ Macrocrystalline HUMAN PRESCRIPTION DRUG LABEL 2 33261-160 CAPSULE 75 mg ORAL NDA 28 sections
Nitrofurantoin Monohydrate/ Macrocrystalline HUMAN PRESCRIPTION DRUG LABEL 2 33261-160 CAPSULE 25 mg ORAL NDA 28 sections
Nitrofurantion Macrocrystals HUMAN PRESCRIPTION DRUG LABEL 1 33261-226 CAPSULE 100 mg ORAL NDA 25 sections
Nitrofurantoin HUMAN PRESCRIPTION DRUG LABEL 1 40032-450 SUSPENSION 25 mg ORAL ANDA 20 sections