NDC 51079-348

Nitrofurantoin Monohydrate/Macrocrystals

Nitrofurantoin Monohydrate And Nitrofurantoin Macrocrystalline

Nitrofurantoin Monohydrate/Macrocrystals is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Inc.. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

Product ID51079-348_7df4a376-15d3-655e-e053-2991aa0aff28
NDC51079-348
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin Monohydrate/Macrocrystals
Generic NameNitrofurantoin Monohydrate And Nitrofurantoin Macrocrystalline
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-02-12
Marketing CategoryANDA / ANDA
Application NumberANDA076648
Labeler NameMylan Institutional Inc.
Substance NameNITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active Ingredient Strength75 mg/1; mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51079-348-20

100 BLISTER PACK in 1 CARTON (51079-348-20) > 1 CAPSULE in 1 BLISTER PACK (51079-348-01)
Marketing Start Date2007-02-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-348-20 [51079034820]

Nitrofurantoin Monohydrate/Macrocrystals CAPSULE
Marketing CategoryANDA
Application NumberANDA076648
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-12
Marketing End Date2019-05-31

NDC 51079-348-01 [51079034801]

Nitrofurantoin Monohydrate/Macrocrystals CAPSULE
Marketing CategoryANDA
Application NumberANDA076648
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-12
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:d08bda24-bc54-4e1f-81e0-5d14b50af107
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648755

    • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]
    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]

    Medicade Reported Pricing

    51079034820 NITROFURANTOIN MONO-MCR 100 MG

    Pricing Unit: EA | Drug Type:

    51079034801 NITROFURANTOIN MONO-MCR 100 MG

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Nitrofurantoin Monohydrate/Macrocrystals" or generic name "Nitrofurantoin Monohydrate And Nitrofurantoin Macrocrystalline"

    NDCBrand NameGeneric Name
    0378-3422Nitrofurantoin Monohydrate/MacrocrystalsNitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline
    51079-348Nitrofurantoin Monohydrate/MacrocrystalsNitrofurantoin Monohydrate and Nitrofurantoin macrocrystalline
    68071-4535Nitrofurantoin monohydrate/macrocrystalsNitrofurantoin monohydrate/macrocrystals
    76413-115Nitrofurantoin Monohydrate/MacrocrystalsNitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline
    42291-574NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-4570NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-4591NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50268-625NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    53002-7042NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    55700-794NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60687-633NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60760-478NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    67296-1640NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    68071-4531NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    68788-7276NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    70518-0799NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    70934-129NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    71335-0863NitrofurantoinNitrofurantoin monohydrate/macrocrystals
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