NDC 0378-3422

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 Pharmaceuticals Inc.. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

Product ID0378-3422_166f4231-3820-4b3c-859d-bc276ea52175
NDC0378-3422
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin Monohydrate/Macrocrystals
Generic NameNitrofurantoin Monohydrate And Nitrofurantoin, Macrocrystalline
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2004-03-23
Marketing CategoryANDA / ANDA
Application NumberANDA076648
Labeler NameMylan Pharmaceuticals 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 Through2020-12-31

Packaging

NDC 0378-3422-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-01)
Marketing Start Date2004-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3422-01 [00378342201]

Nitrofurantoin Monohydrate/Macrocrystals CAPSULE
Marketing CategoryANDA
Application NumberANDA076648
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-03-23

NDC 0378-3422-05 [00378342205]

Nitrofurantoin Monohydrate/Macrocrystals CAPSULE
Marketing CategoryANDA
Application NumberANDA076648
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-03-23
Marketing End Date2014-10-13

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:137038a6-12ed-47fd-a97c-01073c5141d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648755

    • Pharmacological Class

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

    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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